Moderna

Terrible dizziness, lightheaded, overall feeling like something isn?t right in my body almost a nervousness ,chest pain, tingling to right hand and right side of my head, also have nausea, headache unrelieved by Tylenol or ibuprofen.

starting 10 minutes after the vaccine was given my mouth was very briefly tingling, warm wave came over me, my heart starts to race and del lightheaded. they told me to lean back and relax and it went away in less than a minute.

Pt developed racing heart rate about 5 minutes post injection. HR jumped as high as 156 recorded, stayed high for a few minutes then went back to normal. Over then next 30 minutes had multiple episodes of her HR jumping up again and then going back to normal. Pt received a dose of benedryl to treat symptoms. Pt monitored for 1 hour at which time she was felt to be stable. Pt provided with instructions to go to ER if symptoms reoccur.

Patient received Moderna vaccine on 12/23/20 at approximately 1530. No adverse events observed immediately following injection. Approximately 12 hours later (12/24/2020 @ 0300) patient developed fever, chills, body aches, fatigue and headache that last for approximately 24 hours. On 12/24/2020 @ 1200 patient experienced near syncopal episode. On 12/24/20 @ 1500 patient developed hive on b/l legs and arms. Symptoms treated with motrin and benadryl. All symptoms resolved by 12/25/2020

Pt experienced nausea, shortness of breath, chest tightness and anxiety and then lost consciousness. Vitals were obtained several times during the medical intervention. Respirations were within normal limits throughout, BP was 135/89 initially, then rose to 210/110, then declined to 180s/? prior to EMS assuming care. Heart rate was 47 initially, then rose to normal limits. Treated with epinephrine, Benadryl and ammonia smelling salts and transported by ambulance to hospital.

Approximately 11:00pm on 12/29/20: Hives/itching on bilateral hands/wrists/forearms/lower legs/ankes, red face/swelling on face, rapid pulse, headache, nausea, extreme fatigue.

I got the shot, didn?t feel it at all so it went good. I went to the bathroom and went pee and got my arm back in my long sleeve shirt under my scrub top. I wasn?t anxious about getting the vaccine. Then I went to sit down and be monitored. After about another minute I felt very weird like a warm feeling going all over my body. I started pulling my mask away from my face to get a deep breath. Then I broke out in a sweat from head to toe. I think I became pale (I apparently didn?t look good). I started feeling more ?weird? as I had never felt this way before and I stood up to walk because the nurse there wanted me upstairs near the ED but I was weak so I sat down and had tunnel vision. After that it?s a bit of a blur. After I stopped sweating I got very cold and shaky but vitals were ok. It scared me because I have never had a reaction before to a vaccine.

Racing heart- began directly after injection. Continued for hours. Hyperactivity/sleeplessness- feeling of being wired. No sleep for 43 straight hours. No feelings of tiredness or exhaustion during this time. Hives on left arm, upper chest, and abdomen- began at 36 hours post- injection. Benadryl 25mg taken. Treatment successfully cleared hives without further treatment needed.

Patient presented to receive COVID-19 vaccine, received vaccine at approximately 10 am. Patient waited 15 minutes for observation and left observation area without complaining of any sx. Patient returned a few minutes after reporting tongue tingling which eventually got to her lips. . No difficulty breathing or any other sx. No history of allergies. NP/RN administered PO Benadryl 25 mg. As of report of this iReport no additional symptoms or intervention needed. Last vitals: 131/83 75spo2. BP higher than usual per patient, sp02 normal.

Within 10 minutes of receiving the vaccine patient began to look sleepy and started to gasp for breath. She called for help and slouched over in a chair and was moved to lay on the floor. Her feet were elevated and 911 was called. Epinephrine was given, patient responded by being able to gasp for breath and her face returned to a more natural state. Within 5 min she began to struggle to breath and epi was given again. Some improvement did occur. EMS arrived and she was taken to the hospital.

The 23rd within the first hour my arm had gone numb, I do have the similar reaction with the flu vaccine. Within the first hour I felt dizzy and I was going to pass out and nausea. I completed the rest of my shift, not sure how I did it. I woke up in the middle of the night with a head ache and not feeling well. On the 24th I started sweating and dry heaving very bad and had no temp. I was in and out of the bathroom the entire shift. The next day (25th)I woke up and thought I had the flu, my lymph nodes in my throat had swollen and I just felt bad the entire day. The fatigue and exhaustion was un believable. By the 28th I started to feel much better. Then everything returned back to normal.

One hour after my shot I started with dizziness and I felt like I was going to pass out. I felt like my blood pressure was low, but it was really high 160/90. My heart rate was up in the 160's. This continued all day the first day and still continues randomly to today. Yesterday I had a random migraine , and today I am running a 100.2 temperature.

fast and racing heartbeat, chest pain, dizzy and weak, shortness of breath only lasted 2 days after vaccine was given and then stopped.

RN received her first dose of the Moderna Covid Vaccine on 1/6/2021 at approximately 0615 at hospital. Within 5-10 minutes patient noted that her heart was racing and pounding in her chest. Hospital RN went and assessed patient- color pale, heart pounding. HR-157, B/P-135/105, O2 sats-100%. 0630-Ambulated with patient to ED area and sitting in recliner. C/O of dizziness, chills and heart continues to race. HR-148, B/P-150/83, O2 sat-100%. Patient given warm blankets. Patient had not eaten yet this morning so was given apple juice and cracker. Tolerated well. Patient states her mouth is tingly and is very dry. Drinking fluids with out problem. 0640-Feeling better, chills- given warm blankets. HR-105-110, B/P-113/71, O2 sats-100%. 0700-Spoke with ED physician-plan to observe for 1 hour if no improvement will evaluate further in ED. Patient denies any swelling, itching, difficulty breathing. HR-104, B/P-121/79, O2 sats-100%. 0715-Patient is experiencing waves of chills, dizziness and then feeling better. HR-97, B/P-118/78, O2 sats-100%. 0730-Patient continues to feel better but has waves of dizziness and chills. HR-90's, B/P-118/70, O2 sat-100%. Patient was able to tolerate walking to BR without problems. Patient has opted to go the Health Clinic for further evaluation. Family is coming to pick up Patient following this. Patient hasw been instructed to register for V-safe, complete the Covid Intake form and call the Covid Hotline. Patient tolerated walking to the clinic without issue.

at 1210 patient received the moderna vaccination o. 5ml in her left arm she went to sit down and at 1218 she stated she doesn't feel right she got all panicky and restless. we placed a pulse ox on her her HR was high 160's oxygenation 100% BP 158/88 she said her heart felt like it was racing and she was all hot and her lips were tingly.... another RN present said her lips looked a little blue at one point rapid response called . Patient stated she felt a little better, heart rate was in 120's rapid response team decided to send her to the ER for observation

0625-Employee began to have elevated heartrate, heart pounding in her chest. Color pale. VS-HR-157, B/P-135/105. O2 sats-100% 0630-Ambulated to ED room. HR-148, B/P-150/83, O2sats-100%. Drank apple juice and ate a cracker. Experiencing dizziness, chills and heart racing. 0640-Hr-105-110, B/P-113/71, O2 sats-100%. Feeling better, shaking incontrollable chills. 0700-HR-104, B/P-121/79, O2 sats-100%. Spoke with ED physician-observe for 1 hour and reevaluate. Denies swelling, itching or difficulty breathing. Her mouth is very dry. Tolerating fluids without issues. 0715-HR-97, B/P-118/70, O2 sats-100%. Continues to experience waves of dizziness and chills. Episodes are spacing out further and not lasting as long. 0730-HR-90's, B/P118/70, O2 sats-100%. Tolerated ambulating to bathroom without problems. States just not feeling herself. Has opted to go to the clinic for evaluation. Assisted to clinic-tolerated ambulating without problems.

Patient experienced an episode of SVT and then sinus tachycardia for approximately 6 hours after injection

Patient received vaccine and completed 15 minute observation without incidence. Patient went home. Patient's mother-in-law (MIL) was working as a MD today. About 2:15pm, the MIL notified a staff RN in the clinic that her daughter-in-law (patient) was c/o of tachycardia. The patient called her PCP who recommended she use her prescribed epi-pen and go to the ED. The MIL told the staff RN that the patient had a history of allergies and carried an epi-pen. The MIL left the clinic at that time and we have not heard any update from her or the patient. In Item 21, I selected "Emergency Room," but do not know for certain if the patient went to the ED.

Increase in blood pressure, feeling of "ice sensation down vaccination arm (Left), was ok during the 15 minute observation period then returned and requested EpiPen, felt swelling may be starting, 1 Epi pen administered and 911 called, EMS took patient to local hospital for additional observation and treatment if needed.

Nausea, stridor, tachypnea, dyspnea, and epistaxis occurred within 15 minutes of vaccination. The patient's respiratory status declined rapidly. 2 epi pens were administered with no improvement. A 3rd epi-pen, IM Benadryl and high flow oxygen via non-rebreather were administered/applied. The patient showed a decline exhibiting dyspnea and decerebrate posturing. A 4th epi-pen was administered, after approximately 1-2 minutes the patient began to improve. Care was transferred to EMS and the patient was transported to the local hospital. This event occurred over the course of approximately 20 minutes.

After receiving the vaccine, I went into a waiting room for the post-vaccine 15 minute observation. Approximately 2 minutes after sitting down I felt a sensation that can be described as a wave through my body. It only lasted for 10 seconds; however, it was immediately followed by a rapid heartbeat. It almost felt as though I might pass out (I have never passed out before). I alerted a nurse, and she monitored me for the 15 minute duration. After about 2 minutes, I felt 'normal' again.

Patient c/o of fast heart rate and dizziness. No signs of pallor, diaphoresis. No c/o of SOB or chest tightness. Treatment: Assessed heart rate of 108 BPM. Informed patient to take slow, deep breaths, remain seated and drink water. After 10 mins, patient feels much better and had no more complaint of dizziness. Heart rate assessed and it's WDL. Reminded pt. to just rest at home, avoid any extraneous activities and call PCP if any chest tightness or shortness of breath occurs.

Tachycardia "scratchy throat, fuzzy feeling tongue neck beginning to swell" Narrative: monitored for 4 hours and discharged to home with epi pen,

Chest tightness, nasal congestion, light headedness within 15 minutes of injection. 2 hours later chills, headache, fatigue.

8 days after vaccine the injection site was hot to touch, red, swollen. Mild Chest pain (sternum area) since one day after vaccine. Day 9 swelling, redness and tingling at site Day 10 swelling and redness improved but pain in shoulder and neck area started on left side. Tingling and numbness on left side of face. Day 11 pain in neck and shoulder cont and face tingling left side.

Felt heart fluttering within a few minutes after receiving vaccination. Became tachycardic with my heart rate increasing to 140s along with light headedness, nausea and dizziness.

I received the vaccine. I was sitting with another group of nurses maybe about five minutes after the vaccine talking. One of the nurses noticed I had a red area on my left forearm. After, I started to feel strange, body tingling, light headed, my heart started racing, I broke out in Hives on the left arm, neck, back, ear, side of face. It felt like I could not swallow on left side. Was brought to ER was put on oxygen, given 125 solu-medrol IV, Benadryl 50mg IV, and Pepcid IV and 1liter of fluid. Was in observation for two and half hours, improved. Was send home on five days worth of steroids and Pepcid

At 1218 upon arrival to the car, pt complained of "itchy throat, racing heart, flushed face and not feeling well." Reassurance provided. Stated she had eaten and could drink fluids. 911 called. Vital signs obtained: 120 heart rate, 140/60 BP, 112 heart rate, 120/62 BP. Pt denied any previous types of reactions and/or anxiety concerns. Cool cloth to forehead, deep breaths encouraged. EMS on site at 1230 to evaluate. Pt was awake and breathing at time EMS arrived.

-Pt received COVID19 vaccine (Moderna) at MDLS on 1/8/2021 at 9:51 PM. -Pt was observed for the recommended 15 minutes but then came back at 2:13PM with a little rash on her face and chest. -Denies headache, shortness of breath, difficulty breathing, chest pain, dizziness, numbness/tingling, N/V, rash anywhere else on her body, difficulty swallowing, itchy/sore throat, itchy/watery eyes, congestion. -Vitals were stable (see vitals). -Pt was observed for 30 min & did not have worsening of rash or other symptoms. -Discharged after 30 min.

Racing heart, tingling sensation and ?heavy, full? feeling in the face; dizziness, confusion, difficulty concentrating and flushed face. Racing heart began within the 15 min waiting period but I interpreted as anxiety. Other symptoms began roughly 3 hrs post-vaccination. Remedy was to leave work and go home, lay down in bed, and wait. After a few hours symptoms mostly resolved, but face still feels strange (slight numbness and slight tingling).

The patient received the first dose of Moderna Covid vaccine at their place of work on 12/22. They had no complaints after initial vaccination. On the morning of 12/23 the patient experienced light headedness, diaphoresis, tunnel vision, low blood pressure of unspecified and what could be described as a near-syncopal event. Patient states they did not lose consciousness or fall during this event. Patient then called EMS and was taken to ED by which time symptoms had mostly resolved. Still had complaints of general fatigue and arm pain. Patient received no medications and was supervised for 2-4 hours before being discharged. Of note patient previously had COVID in June and was hospitalized for 6 days, the patients pulmonary function remained stable during that admission.

Patient began to feel numbness and tingling in fingers and toes 15 minutes after injection. Was given water and support. 30 minutes after injection stated her throat was numb, her tongue was tingling and she had a very dry mouth. BP was slightly elevated at 133/100. Pt seemed very anxious and was given emotional support. Epi was on standby, discussed course with MD and was advised to wait giving epi unless symptoms worsened. 45 mins after injection symptoms were worsening. Pt able to breath but mouth and throat tingling was worsening. Called 911 to provide observation in case symptoms worsened. Pt agreeable to being observed in ED.

Awoke at 3 am with severe chills, diaphoresis, nausea, vomiting, diarrhea and headache. Syncope episode within that hour. Worsening full body joint and muscular pain which became severe by 8am lasting until around 7pm. Able at this time to tolerate 400 mg ibuprofen without vomiting and gain control of pain level. Continued, more mild headache, body ache, fatigue, presyncope and diaphoresis lasting until following day.

swelling at site of injection, dizzy and heart palpitations within minutes high blood pressure tingling of arm and nausea call ems blood pressure went down within 10 minutes fill better and able to leave after 30 minutes was stable when ems arrived and did not take pt to hospital pt rested and left follow up with pt a few hours after at home and was feeling better

Around 12 hours after time of vaccine dose until 28 hours post-vaccine, I felt very nauseous, had intense body aches, chills, shivering, body weakness, rapid heart rate (around 120), decreased O2 sat (around 90), and difficulty breathing. Symptoms came on very suddenly (around 10pm on the day of the vaccine) and ended very suddenly (around 2pm the next day). Body was still weak once recovered.

Had Moderna 1st shot on Jan 7. Eye infection that night and the next day. Then, Saturday the 16th, a tickle in my chest.. soon produced a dry cough in relief/response to the tickle. Next day, I was hoarse (Sunday the 17th). Still hoarse. Sore throat off and on. Headache. Body aches. Incredible arthritis-like ache at the tops of my shoulders, upper back, and neck. Runny nose. Spitting mucous - was clear, now some thick solid white. Chest pain in the middle that comes and goes. Chest pain on left center side - it feels like in the area of my heart. Ache in my lower left side. Today, aching in my jaws mostly left side, but both. Ache on upper right front (lung area?). INCREDIBLY tired. It's so hard to stay awake.

Dizzy, shaking, runny nose, tachycardia, high blood pressure, nausea. Could not obtain IV access after multiple attempts. Benadryl given IM. Steroid course and pepcid prescribed.

On January 4 at 2:00 pm I suddenly started to bleed from the nose from the left nostril and then from both. The event lasted more than 35 minutes so I had to go to the ER. The diagnosis was Epistaxis. I was discharged because at the time of the medical evaluation I removed a large clot from my mouth and the bleeding stopped. Appointment with primary physician for diagnosis and appointment with ENT was ordered. On January 5 at 4:15 am I had another episode of nasal bleeding lasting 25 min. After removing a clot through the mouth, the bleeding stopped. At 4:00 pm I presented Epistaxis again so I had to return to the Emergency Room. I was reevaluated and the instruction was to visit the ENT and Afrin prescription for three days and Claritin D q 12 hrs PRN. From January 6 to 9, I began to eliminate a serous-bloody vaginal discharge. That began with the elimination of a clot and progressively diminished day by day. January 11, 2021, the ENT evaluated me and indicated that it did not observe polyps or anatomical problems. I had not previously prolonged nosebleeds. Previously two minor episodes happened to me, a year ago that resolved in less than 7 minutes. I didn't have a cold or any other symptoms. I want to raise the flag because it was a strange event that occurred after the vaccination and that I had not experienced before in that way.My next dose is January 29, 2021. I am awaiting clot test results

Woke up 1/20/21 with chills but no fever, increased heart rate of 99 when my normal is 68, dehydration, headache, fatigue, body aches, injection site pain, nausea after eating oatmeal and coffee.

Patient received her vaccine and was taken to the observation area to be observed for a 15-minute period. In the observation area, she immediately reported "feeling funny" and was noted to be "sweaty". The advanced practice nurses and pharmacist were called for assistance immediately. She was placed on a stretcher, had her legs elevated, and was moved to a quieter area. She was responsive to commands and her vitals at this time were as follows: blood pressure 96/56 mm Hg, oxygen saturation of 96%, and heart rate in mid 60s. She did not require treatment and within several minutes of lying down on the stretcher felt better. She did not have any rashes or swelling, and she denied difficulty breathing. She was observed for about half an hour in this area and was also evaluated Emergency Medical Services who had been called. It was suggested that the patient should visit the Emergency Department for observation but she refused as she felt better and due to concerns of being exposed to Covid-19. We were able to walk with her escort her to the exit area at the end of the observation period. We questioned her about potential allergies again and she denied a history of allergic reactions. The advanced practice nurse evaluating the patient suggested this episode was consistent with a vasovagal episode and that anxiety could have also played a role.

started having asthma attacks (chest pain and Shortness of breath with wheezing) on friday 01/15/2021 Didnt get any better over weekend. was taking inhaler every 3-4 hours. Monday was tested for covid which was negative. body aches and fatigue began over weekend. asthma progressively got worse. On 01/20 had to visit dr office, my neck was swollen on both sides, injection site had a raised large area that extended from my shoulder to my elbow. Up until yesterday, you could not even tell where I had the shot. Now there is still a raised area and you can tell exactly where i recieved it.

Patient reported feeling "funny", became clammy and cool, pale for several minutes. Patient reports similar symptoms previously with other injections.

stated she sometimes faints, and then proceeded to faint. Contacted EMTs from observation who lowered her to the ground safely where she regained consciousness. Observed in room for 15 minutes. Was able to get up and move without assistance. Went with EMT to observation area without any assistance. Pt HR 72. Lying on floor up to 1 minute. No falls. Lying on floor up to 1 minute. Vasovagal response consistent with previous reactions post-vaccination. Currently seen sitting upright in chair A/Ox4, denies any discomfort, denied offer for fluids or food. Smiling. Treated by paramedic and RN.

Client received the vaccine at 4:30 pm. Client to be observed for 15 mins after. Client stated she felt fine around 5-10 mins after vaccine. At 4:45 pm client was going to be released but stated she felt some vertigo and felt like "the words on the picture are blurry". Client's BP 168/110 and P 112 at that time. Client encouraged to drink some water, take deep slow breaths and talked about. 15 mins later her BP was 140/84 and P 104 and client stated she felt a little better. Client got up to use the restroom at that time. Client denied any history of high blood pressure but did state her "normal resting heart rate" is higher than most people. BP taken again approximately 15 mins later and 156/100 and P 104. Client stated she felt better but "my heart still feels like it is racing" Denied any shortness of breath, feeling of throat swelling, or itching. Client did state her "chest felt a little tight" but stated "I am fine". Advised client to be evaluated at ER. Client went to ER.

Pt c/o feeling faint, dizzy and tachy. Vitals were assessed- b/p 160/72, pulse 131, o2 99%. Pt assisted to the floor and feet elevated. MD notified and assessed pt at 12:14pm. Injection site clear of any reaction. At 12:16 vitals reassessed- b/p 142/70, pulse 91, o2 100%. Pt sat up in chair and porvided water. Monitored for 20minutes. D/c'd per MD.

30 minutes after vaccine experienced hot flashes, heart flutters, shortness of breath and increased heart rate, dizziness, confusion. 15 hours after vaccine begin having chest pain, continued increased heart rate, headache. Went to the emergency room with chest pain, shortness of breath, heart rate 133 and blood pressure 169/93. 48 hours after vaccine had low grade temp, dizziness and pain at injection site. 72 hours after vaccine pain at injection site.

Approximately 5-10 minutes after injection, I began to feel dizzy and my heart started to beat rapidly. The nurse checked on me and it continued to get worse. They checked my blood pressure. It was extremely high, 166/1 Over the course of the next 45 minutes my Blood Pressure continued to stay high. The dizziness would come and go. I was escorted to the ER. I refused an ambulance. The ER did an EKG, hooked me up to a heart monitor and monitored my blood pressure for about 2 hours. They finally let me leave when my Blood pressure came down to 135/100 and I was not experiencing anything but minor dizziness and a headache. The headache continued on through the night and by 3:30AM I had a migraine. I took Sumatriptan and after an hour the headache subsided.

Patient has history of dizziness with vaccines. She received vaccine and was asked to wait for 30 minutes for observation. After about 5 minutes patient got nauseous and got up to throw up. She collapsed on her way to the bathroom. She remained coherent the whole time. 911 was called immediately and patient was taken the hospital.

Patient here for 2nd dose covid moderna vaccine. Reports that during her first dose, she had lightheadedness, increased BP, heart racing, acid reflux, symptoms resolved in 10 minutes. She was cleared by her PCP to receive the 2nd dose. On 1/23/20 at 1044, patient received her second dose moderna vaccine. At 1050, she reports feeling "heart racing", excessive acid reflux. VS at 1050, 165/95, HR 135, O2 100%. She denies n/v. +excessive burping. At 1055, VS BP 139/99, HR 95. O2 100%. Continues to have burping sensation. At 1114, VS BP 127/88, HR 86, O2 100. Provided fluids and snacks. Reports symptoms improved. But continues to have excessive burping. At 1129, BP 126/89, HR 107, O2 100%. Patient reports symptoms improved. Denies chest discomfort. But reports that she continues to have burping, relays that it is likely due to her history of gerd. She have not taken her medications yet (she takes omeprazole daily). At 1150, BP 151/94, HR 109. Patient reports feeling anxious , continues to have excessive burping, no heart palpitation. Transferring patient to ED. Patient initially declined and would like to go home instead. Discussed with patient and risks and benefits. She then agreed to go to ED for further evaluation. Patient was safety escorted to ED.

12:52 pm - face/mouth area feels itchy; heart palpitations occur; 12:56 pm - face starts getting blotchy with hive-type mark near mouth; 1 p.m. - body starts feeling itchy allover; Around 1:20 pm the mouth hive seems to have gone away and the itchy is less bothersome. By the afternoon, everything seems to have subsided. Arm is very sore the next morning.

5 minutes after I the vaccination I got light headed and heart palpations were felt in my throat, elevated BP of 148/92 which continued to increase to 159/109 which then Rapid Response was called in and I was transported to ER for about 4hrs. 2 EKGs - done 1st showed PVC, and Cardiac labs were drawn and was continued monitoring with elevated BP. About 3hrs later ,the 2nd EKG was done which looked better and I was released. I was advised I could return back to work on 1/1 but I still felt bad and had continued palpations and wasnt able to go bk to wk until 1/5. I did return to work on 1/5 and at 1:30am I got up and felt lightheaded and the palpations returned. I went to healthcare facility and got my bp taken which was 174/92 so I went to the ER. I was given presnisone and within the next 45min the palpations began to lessen and BP began to decrease. I was also prescribed a 7day course of predinsone and removed from work until 1/9. I had a virtual visit on 1/7 with my physician in which I showed her the injection site which was still very red, painful and bruised so she prescribed Bactrim and Benedryl causing her to further remove me from work until 1/14. I had a in person follow up appt on 1/14 which by that time all symptoms had subsided. My BP was back normal at 97/72 and my arm symptoms had subsided as well. An in office EKG was done which was normal. But from 1/6-1/14 the heart palpation and elevated BP remained. Although I will say they did lessened throughtout that time it was extremely hard on me during that time frame .

Sudden onset dizziness, near syncope, tachycardia, shortness of breath, facial numbness, shaking/rigors

onset of chest pressure, tachycardia within 10 minute. hives, swelling of lips and upper extremities, shortness of breath, systemic itching, sore throat and change in voice occurred 20 minutes post vaccination. epi-pen administered at onset of hives, etc. taken to ED and given more epinephrine, IV solu-medrol and diphenhydramine. monitored for a few hours and then discharged. 5 day course of prednisone prescribed.

One week post vaccination, developed angioedema of left eye, experienced hives over entire body, tongue itching, scratchy throat, tachycardia

Fever 100.9 at its highest, severe chills, sever headache, sever body aches, resting heart rate 124-130 chest pain and hard to breath. I was unable to work or take care of my children this started 12 hours after having the vaccine. reactions lasted about 12 hours

Went out to car around 25 min after with only mild throat discomfort. Shortly after, was having difficulty swallowing, felt dizzy & face swelling. Took quick release (dissolve under tongue) prednisolone 20 mg (have for peanut allergy). Symptoms didn't initially improve, used albuetrol inhaler and returned to hospital. Swelling symptoms started feeling better. Blood pressure when first checked was very high, still at 170/118 at 21:54. Sent to ED. Wheezing and constant throat clearing in ED, used inhaler again & symptoms improved. BP still high for me at 138/80 at 21:54 with patchy confluent erythema over anterior chest that blanches, non-pruritic & 3-4 hives on abdomen. Given Benadryl 50 mg, famotidine 50 mg & dexamethasone 10 mg at 22:22. At 23:09, chest rash resolved, but pruritis & mild urticaria to back and arms. At 23:41, urticartia resolved & discharged. After second dose of Decadron was delayed the following day, itchy hives returned on chest, stomach, back and left shoulder. Same occurred on the 3rd day, along with wheezing (resolved by other meds & inhaler) and more steroids were prescribed. This resolved the remaining symptoms.

0905 experienced hypotension 97/54 BP rechecked by RN 104/78 Patient had no further symptoms and was ok to go home

Roughly 25 minutes after getting vaccine I passed out and when I came to my throat felt like it was closing and I was very itchy on my neck and chest . Had hives

2 hours after administration, pt has nausea and vomiting. Vomiting lasted 2 days and nausea x 1 week. Pt also experienced headache, body aches, chills and fatigue. No fevers. Pt did note within 1-2 weeks racing heart at times and recurrence of sore throat and mouth blisters (which is chronic/recurrent and being worked up).

immediate metallic taste in back of mouth ( reminded her of iron supplements she takes). The next day felt pressure in chest like indigestion, but she says that happens frequently.

30 minutes after the shot, the roof of my mouth and back of mu throat went numb. Only lasted 15-20 minutes. Extreme fatigue and headache. Fever and epistaxis

1/23/21 got the vaccine. Was fine till the evening. Started feeling the heart rate increasing. Soreness at the site. Fever was 103 that day. Next day 8am noticed hear rate was fast. Still felt hot. During the day heart rate kept increasing started getting sweats. Diff breathing, weakness, dizziness. Wanted to call EMT. But went to the ER on own. BP was high, HR /160. Gave medication for the heart to slow down the rate. Was given Emtoprolol in the ER. Was in the ER for several hours.

Day after receiving second moderna dose, while at work patient omplained of headache and feeling dizzy while sitting at her work station. Pale color, skin warm to touch. Assisted to floor. Brief loss of consciousness and gradually responded to questions.. SaO2 98-99% on room air with pulse 60-70. B/P 118/78 lying. Finger stick blood sugar 124. EMS called to respond. Increased responsiveness and states had COVID immunization second dose yesterday. This AM her legs ached. Had taken ibuprofen for symptoms. Has not eaten food today but has been drinking fluids. Report given to EMS on arrival and care transferred. Reported patient is at home sleeping, plans to return to work 1/28.

Constant Fever despite taking Tylenol around the clock, 103.1. Chills, syncope, seizure, extreme fatigue, nausea, headache, loss of appetite.

About 2-4 mins after injection my left hand and fingers were tingly which lasted a few minutes. I also had tachycardia and dizziness which lasted about 1 minute.

Patient was given vaccine and asked to wait 15 minutes. While waiting patient slumped over in chair. We aroused him and helped him onto the floor, his breathing seemed ok but we called 911. While waiting we kept him talking and he seemed alert. When paramedics arrived they took over. He began to loose consciousness again and they took him in.

1. Abdominal pain, Left side towards the back, leading to 2. vasovagal reaction, near fainting episode. 2-3 hours. 3. Rash covering entire left upper arm at site of injection site and surrounding it

Fainted to the floor; Dizzy; Too dizzy, hot and sweaty; Nausea; A little vomit; sweaty; A spontaneous report was received from a non-health professional who was a 40-years-old, female patient who received Moderna's COVID-19 vaccine and fainted, was dizzy, felt hot, had nausea and vomiting, and sweaty. The patient's medical history included a propensity for fainting and low blood pressure. Concomitant product use was not provided by the reporter. On 12 Jan 2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Lot number: 039K20A) intramuscularly in the right arm for prophylaxis of COVID-19 infection. On 12 Jan 2021, after receiving the vaccine, the patient got dizzy, had nausea, a little vomit, and fainted to the floor. She reported feeling dizzy, hot and sweaty. Patient did not take medication to treat her symptoms. Action taken with the second dose of mRNA-1273 in response to the event was not reported. The outcome for the events, fainted, dizziness, felt hot, nausea and vomiting, and sweaty were unknown.; Reporter's Comments: This case concerns a 40-year-old female patient with medical history of propensity for fainting and low blood pressure who received their first of two planned doses of mRNA-1273 (Lot unknown), and who experienced the unlisted event of Syncope which was considered medically significant. Additionally, the patient experienced the non-serious listed events of Nausea and Vomiting, and the non-serious unlisted events of Feeling Hot, Dizziness and Hyperhidrosis. Based on the current available information and temporal association between the use of the product and the onset of events on the day of vaccination, a causal relationship cannot be excluded and the events are considered possibly related to the vaccine. We would note that the patient's history of propensity for fainting and low blood pressure could be also contributory.

Right after injection felt dizzy immediately. Within minutes chest became tight. blood pressure was taken and read 158/103. pulse ox was 86. evaluated by physician at the vaccine clinic. took 50 ml of Benadryl. Close monitoring continued and 02 went up to 95. Tightness in chest continued throughout the day. Began experiencing abdominal pain approx. 730pm. on 1/13. At 930pm began with worsening severe abdominal pain with continued shortness of breath. At that time, pt. went to the Hospital ER. for evaluation. In the ER, her pulse ox was in the 90's. She received Benadryl, lab work, and CT Scan of abdomen, and was discharged to home. Day 2 pt. continued to experience abdominal pain and shortness of breath. The third day fever and chills. Day 4 body aches. pt. is completely recovered at this time, and is recommended by her health care provider to NOT receive the second dose of the vaccine. pt. s not taking the second dose of the Moderna vaccine.

Pt complained of shooting arm pain down to fingers. Pt stated that she had this with her last moderna vaccination. Site is clear without redness or demarcation. Ice pack applied to injection site. Pt then started to get short of breath and a feeling of discomfort in her chest. Rapid response called and pt taken to emergency room for monitoring. Wheezing noted.

Woke up on day 1 post dose #2 (Jan 27) with hot flashes, anxiety, elevated HR (100's lying down; 140's when up) in addition to body aches, headache. Have lost 5 pounds over previous 2 weeks without trying. HR has been steadily increasing over last month, along with increasing anxiety. Was seen by endocrinologist on Jan 28 who drew lab work and confirmed on Jan 29 that all thyroid labs were elevated. Prescribed methimizole and metoprolol. Will follow up in 4 weeks.

210 am woke up hot. Walked downstairs had ringing in my ear and saw stars, held the wall almost passed out. Began profusely sweating drenching my clothes. Nausea began. Went back upstairs sat on my bathroom floor due to nausea/ dry heave. All of a sudden SEVERE abdominal pain began 10/10. Cried for my husband. Dripping sweat gave me a cold rag and foam large diarrhea began. Still 10/10 pain in abdomen. Felt like my lower abdomen was getting ripped out. About 45 minutes or so later still 10/10 wanted to go to ER. I could not stand. If I stood my legs and body felt like I wanted to curl in a ball on the floor. He called an ambulance. I was pale as a ghost, no fever, normal vital signs. Went into full reynauds flare from body stress. Ambulance was unable to get oxygen sat and glucose at the time due to flare. Arrived at the ER labs drawn. WBC 10.9 and Glucose 194. I am not or never have been diabetic. Vaccine related. Like a lightswitch all symptoms stopped except sweating hot and cold spells, sore arm and drowsiness. Discharged at 6am

Injection site pain, bodyaches, joint pain, muscle tightness, headache, racing heart, fever (100.5), loss of appetite, nausea, vomiting.

12 hours after vaccine, near syncope episode, severe muscle aches and chills,severe vomiting low grade fever100.2, unable to sit up for 12 hours without almost fainting or having to vomit

Bodyache, headache and chills after getting COVAX 2nd shot yesterday. Denies direct contact of COVID19. Tachycardia presents. Otherwise pt is afebrile.

Numbness and tingling in lips and oropharynx progressing to face; flushing and redness on chest, itching of hands, eyes, neck; nausea and stomach cramping all onset approx 30-40 minutes after vaccine. Treated in the emergency department w/ famotidine 50mg, solumedrol 125 mg, 1L NS. Noted frequent multifocal PVCs and runs of ventricular bigeminy during Emergency Dept evaluation and ongoing intermittent facial tingling and itching. Admitted for overnight observation.

Nausea, dizziness, shakiness, chills at about 15 minutes. HR 83, O2 sat 94% increased to 98%, bp 140/90. Ladi down, felt better, ate a cookie, went to check out. Felt nauseous again, laid down again. Developed erythematous rash around vaccine site, then spread to neck and shoulders. then slight chest tightness that rapidly resolved. HR 68 spO2 97%, 119/52. T 98.7. Diphenhydramine 50 IM given. Rash receded. At 13:20, HR 59, 113/59, 98% sat. At 13:35 HR 56, 110/56, 100% sat. Continued to feel better. Fexofenadine 180 po given, albuterol inhaler 2 puffs. Continued to feel better. Picked up by husband.

Moderate chest pain lasting 12 hours and hot/cold flashes, generalized achyness starting at 4 pm day of vaccine. Following lasted started day after vaccine and lasted 24 hours: fever, fatigue, achyness, hot/cold flashes, headache, sore arm, burning nose. Took Tylenol, left work early, went home slept on 1/29/21 additional 5 hours from 3 pm until 8 pm. Back to bed 12 am to 8 am following day

The patient received the 1st dose of Moderna vaccine. She waited 20 minutes for observation without any symptoms. She left and began to drive home in her car when she felt her tongue begin to swell. She returned to the vaccine clinic observation area and was transferred to the ED. Her overall symptoms included tongue swelling, throat irriation, oral and facial swelling, lightheadedness, shortness of breath, wheezing, hypertension (170/118; HR=83), urticaria over chest wall. The patient had self-administered oral prednisone prior to ED transfer. Was further treated with diphenhydramine, famotidine, and dexamethasone. Discharged to home after 3 hours. Follow-up notes report symptoms resolved by 2 days post-discharge.

All over flushed feeling and generalized tingling. Blood pressure elevated on assessment: 9:46am- 179/111, 9:48am- 168/120, 10:48am- 129/77, 10:00am- 151/104. started within 5 minutes post-vaccine lasting approximately 40 minutes

With in 5 mins of getting my shot I started to get sweaty and my heart starting getting bad palpitations. I could feel myself get super flush, I could feel my whole body warming. I had a hard time swallowing and my tongue burned and felt swollen. My throat would just get super tight. Each episode lasted under a minute This happened on and off it for about 30 minutes. Each time it happened it was not as bad as the time prior. I was dizzy when I tried to stand up and I sat and was monitored for an hour. They administered Benadryl. I have some edema on my upper chest when I got home. I was super tired too. The next day still the edema and I have a sore throat . I explained the best I could to the pharmacist when it was happening . I refused to get EMT because it was not constant and it was getting less intense each time.

Chest tightness, fever, pain, redness, swelling at injection site, swelling at clavicle and arm pit Left side, hot flashes

Shaking throughout entire body started 20 minutes after injection. Blood pressure dropped low, weakness and dizziness. Shaking changed from. Small shakes to larger jerking. Toes and fingers continued twitching for 2-3 days.

Rapid heart rate at the time of vaccination of 146, heart rate back down to normal until 20 minutes post vaccine with heart rate spike of 138. Heart palpitations for 5 hours post vaccine. Symptoms resolved at 2:00pm on 01/28/21

1 hour after injection, pt c/o palpitations and a brief episode of her lips suddenly felt cold and then quickly returning to normal. She has also has experienced palpitations intermittently in the weeks following vaccination.

Nausea, vomiting, sore arm, redness, swelling, warmth, headaches, body aches, hot flashes, mind fog, fatigue, racing heart lasting 5 days.

patient started to have trouble swallowing and scratchiness in her throat. This worsened so she received benadryl 50 mg po. Pt was feeling hot and was diaphoretic. Pt monitored. Started c/o chest tightness. Was transported to the emergency room.

nausea, trouble swallowing, chest tightness, dizziness. Taken to ED. Given Benadryl 25 mg IV, Epi 0.3 mg subcutaneous, methylprednisolone 125 mg IV. Discharged home with steroids and Benadryl.

Within 30 seconds had metallic taste in my mouth. Approximately 1hr 15 minutes later I began to experience swelling of the tongue, scratchy throat, headache, heart palpitations and nausea, which progressed through the evening. Benedryl was taken PO at approximately 2005. At HS (approx. 2230) tongue was still swollen, though not grossly. In the morning my tongue was slightly swollen, but improved. All other symptoms persisted for 3-4 days.

Ten minutes after vaccine became dizzy, diaphoretic, tachycardiac and hypertensive. Felt better went home started vomiting With dizziness. Went to ER. Admitted for 3 days. Still suffering from dizziness and under care of ENT doctor being treated now for BPPV

Pt stayed 30 min for monitoring d/t hx of allergies. 2 hours after admin developed wheezing, chest tightness, diarrhea. Went to ED, had severe diarrhea, throat swelling, chest tightness, DIB, n/v; pt received IV doses of steroids, benadryl, IM epinephrine, racemic epinephrine breathing treatments x2; and duoneb tx's every 2 hours. Pt required overnight admission to the hospital for monitoring as had some persistent symptoms.

Vaccine Administered: 1344hrs Reported Reaction: 1355hrs While in post-vaccination area, pt suddenly stood up and complained of feeling light headed and had some tightness in her chest. Ambulated outside of classroom for fresh air. Stated she felt better with fresh air. Chair made available for pt but would sit and then stand. She did this twice until just standing. Vital signs taken - stable. Water offered but refused. Chair offered but sat only for a little due to wanting to stand. Monitored until symptoms resolved. Discharged at 1413hrs.

35 weeks 4 days pregnant at time of vaccination. 60 hours after injection (on 1-23-21 at 10:30 pm) developed fever of 103, severe chills and tremors, low blood pressure (80/60), high resting heart rate (115 beats per minute). Treated with acetaminophen. Symptoms continued for a week, with ongoing fever spikes of 103 and dips down to about 100. Requested antibiotics from OB on 1-28-21 and began taking amoxicillin that evening. Symptoms began to lessen by 1-29-21 and disappeared after 1-30-21. OB tested for UTI on 1-28-21; returned positive result on 2-4-21.

On Jan 1st-3rd felt so tired I couldn?t get out of bed. Slept almost 24 hours a day. Morning of Jan 3rd I had a seizure. I have no memory following the next 36 hours. Spent 3 days in the hospital. Cause as yet I know. EEG during hospital stay and again on Jan 29th showed no unusual activity. Mri and CAT showed nothing abnormal.

Intermittent sharp pain, dizziness and lightheadedness. Patient reports anxiety, left-sided chest pain (2-6/10) that comes and goes. Mild SOB. No signs of heart attack. BP 118/73, HR - 85, respiratory rate 20.

Since receiving my second shot, I have had 3 bloody noses. I never get bloody noses. Im not sure what this is from.

Top lip tingling, swelling, itching all over body, rapid heart rate, throat felt "thick" had to keep clearing throat or drinking

Pt states felt poorly, chills fatigue, body aches day after vaccine. Pt experienced fever and a "foggy Head". Pt left work place early, does not remember driving home and states she fainted in her garage, her husband found her. Pt is uninjured, has hx of moderate aortic regurgitation. Pt did go to work today, states feeling much better, pt will see PCP today for follow up

Sustained tachycardia at rest 120-130 heart rate for two hours and high blood pressure accompanied it on the morning of 2/4/21. Resting heart rate for 24 hours was 100.

After injection waited in medical observation due to medical conditions, developed Severe Headache, blurry vision, & Increased Blood Pressure.

I started my menstrual cycle about one week early, experienced dark, brown tinged spotting for 2 days followed by heavy flow with more clotting than I have ever experienced before. Cycle lasted about 8 days, versus my normal 4 days. These symptoms concern me due to several reports of miscarriages while receiving vaccine.

After 2nd dose chills started in middle of night. Experienced severe nausea, diarrhea, vomiting with extreme pain in lower back and hips. Intense headache that lasted for over 1 week close to 2 weeks causing me to have to call off work. Large painful lump in left axilla that lasting 2 weeks. Axilla remains to be tender to touch. Also, had sweats after the chills subsided. Thought that my blood pressure was elevated, but now I am relating the elevation to the 1st injection. I have never had hypertension and after 1st dose blood pressure went as high as 160/104.

Topamax is the only new medication. Been taking 4 months. When full blood work up was done for department of infectious health all labs were optimal. On Feb 5 was admitted to the ER with Hypokalemia potassium level of 2.6 and arrhythmia

Immediately after getting the 1st vaccine I had a very sore arm that lasted about 3 days. 2 days it was so sore that I took 800mg ibuprofen every 6 hours and put heat and ice on site for 20 min on 20 min off and alternating for 2 days while awake. No other symptoms. For 2nd vaccine, the vaccine itself was extremely painful (burned and pain at site and tingled down to fingertips for a few hours. Applied pressure as I bled for 10 min after administration. Followed by ice off and on for 20 min for first 2 hours. At 22 hours, I started to feel nauseated and lightheaded and had mental fogginess. The following morning, I awoke around 3am and was very ill with flu like symptoms. mild temperature of 99.8, chills, body aches, fatigue, rapid pulse, headache, sore throat, and mental fogginess. This lasted for approx. 36 hours. The worse symptoms were the headache, fatigue, and severe body aches that lasted for 72 hours after vaccine.

Noticed extra fatigue evening after vaccine adminisrered. Fatigue, dizziness, tremors when I awoke the next morning and increased with time. By 6 am, felt very dizzy, vertigo and as if limbs and head were filling with lead. Felt like I was going to go down so layer on the floor at work. Coworkers took me to the emergency department. Symptoms ongoing, lost consciousness multiple times, through today. Not able to work since emergency room visit.

Feeling fatigue and arm pain. 02/06/21 - Woke up with body shakes, chills, muscle ache and pain. 02/07/21 - Vomitting & fatigue 02/08/21 - Chest tightness

The evening after she received the first dose of the Moderna vaccine she developed mild chest pressure and felt itchy. Pt took 25mg of Benadryl and when she woke up the morning after she had moderate hives on her face, neck, chest and arms. Pt took 50mg of Benadryl the morning after the vaccine and then came in to Urgent Care. Pt was prescribed prednisone, instructed to take daily Allegra, Benadryl, and prescribed an epi pen for escalating symptoms. Pt was informed to not receive the second dose until she is cleared by allergy/immunology.

Triggered Asthma Attack at 12:30pm on 2/6/2021, Caused throat to become hoarse, raspy and sob. Extreme pain in left arm and swelling of arm and fingers. By 4:30pm on 2/6/2021 Hands Swollen, L Arm Extremely Swollen, Swelling of Lymph Nodes in Throat and L Armpit. Hands, Feet and Face Swollen. Extreme Fatigue and Body Aches, Extreme Headache, Fever 100-101 for 4 days, Vertigo, Dizzy Spells, Nausea, Joint Pain, Teeth Pain, Heart Rate and Blood Pressure Increased. Took albuterol nebs, antihistamine and napoxen, increased fluids, reported to director of pharmacy at work/vaccine site and was on bed rest for 4 days. Broke fever on 2/9/2021 in the evening, fatigue, joint pain, lupus symptoms, migraine, swelling in hands and vertigo/nausea still present as of 2/11/2021. Doctor Appt already scheduled with neurologist on 2/11/2021 at 11:30am, family physician notified but out of the office.

--12/29/2020: Upon receiving the vaccination my heart rate plummeted to 45 BPM and suddenly raised to 134 BPM, thereafter stabilizing within 90 BPM. --01/02/2021: I felt extremely sick all of the sudden while at the same time my Watch triggered and alerted that my heart rate was in the 160's BPM and rising. I was rushed to ER where the medical staff fought to stabilize me and administered three doses of Adenosine to control my heart rate. Since 01/02/2021 I have been battling to control my heart rate with Propranolol. I have been to the ER multiple times weekly and have had numerous appointments with specialist at medical center--they are unable to diagnose me. They cannot find a reason for Tachycardia. Gastro, Endo, BH and Cardiology at medical center have many test, scans, echos, bloodwork and are unable to find cause let alone a solution.

Painful pin feeling stabbing in the back of tongue, tongue swelled, tip of tongue went numb, lips went numb, pain in left part of chest, difficulty breathing, started to break out in hives, bloody nose. The medics did nothing for me as I am allergic to albuterol. After I felt like I could breathe properly, I went back to work and took some allergy medicine to help stop my reactions. It took four hours for the reactions to subside.

moderate-severe adrenergic response within 15 minutes after injection. Pallor, diaphoresis, nausea, dizzy, lightheaded, tachycardia, hypotension, weakness, numb toes, tingling in mouth. Given liquid diphenhydramine at site. Recovered.

Heart palpitations immediately (2/16 at 6:15pm) but subsided within 10 minutes. Nausea started about 8pm night of vaccine along with extremely sore arm. Nausea persisted all night and at 5am felt like I was going to be sick so went to bathroom. Sat down on toilet and don?t remember anything until I woke up on bathroom floor with two knots on my head. Unsure if syncopal episode or seizure as I have multiple knots on head and my belongings from my pockets were strewn about the floor. Body aches began around noon day after shot along with low grade temps and chills. Nausea and headache persists today (2/18) but I am unsure if that is from vaccine or head injury.

Patient felt lightheaded and was unable to stand without assistance. Was hypotensive. IV established and fluid administered IV. Transported to medical center via ambulance.

Patient received 2nd dose of Moderna Covid vaccine at approximately 9:00am. 15 minutes later she started to feel dizzy and complained of chest pressure. She then experienced a syncopal episode with lasted approximately 45 seconds. This patient has not experienced a previous allergic reaction to the first dose. She developed an itchy red rash on her right and left arms. She also reported nausea. In the emergency department, she received Solu-Medrol 80mg, Benadryl 25mg, 1L of NS fluid, Pepcid 20mg, and Zofran 4mg. She was discharged to home via wheelchair once stable. At the time she was discharged, patient was awake, alert, and oriented x3. Patient verbalized understanding of disposition. She was given prescriptions for promethazine 25mg and ondansetron 4mg.

Initially became flushed and warm, followed by rash that developed into hives on the face and chest. Acknowledged headache and blood pressure was elevated.

Client reported that 2 hours after she received her second dose of Covid19 vaccine, she developed heart palpatations, sweating , shaking and her skin became blotchy and red with a rash everywhere. And client reported her arm being very sore and her brain was foggy . She went to the ER and was evaluated and vitals were monitored in the ER. Client stated that she was then discharged and told to take Benadryl and or Ibuprofen for any issues . Today client reports that she is still not feeling 100% has a sore arm and a migraine.

9pm- chills 11:30pm- fever, nausea, vomiting, tachycardia, diaphoresis Husband Called 911 2/24- all day fever, chills, headache, fatigue 2/25 last fever at 10:30am, still have chills, fatigue, headache

extreme dizziness ringing in ears vomiting elevated heart rate elevated blood pressure headache itching sensation under skin nystagmus transported by ambulance from home to the emergency room treated via IV, benadryl, meclizine, anti-nausea medication

Patient complained of having a rapid heart beat , cold and clamy hands and vaccination area was purple in color and hot to the touch. Patient was seen by EMT on site where her blood pressure and pluse rate was monitored. (1) 144/88 , (2) 128/90 , (3) 128/92 . Pulse Rate (1) 103 , (2) 100 , (3) 111. Patient did not have to be transferred to a medical facility and was cleared to return home by EMT .

Moderna COVID-19 Vaccine EUA Within a minute of receiving the vaccine, I walked about 40-50 feet and experienced extreme dizziness and shortness of breath, and could not stand straight. I was able to stop my own fall due to a wall being next to me, and I stooped down close to the floor so as to prevent a fall. I then was able to walk about 20 feet to an office where I could sit and the dizziness continued. I noticed I was shaking and heartrate was elevated (that could have been the anxiety caused by the dizziness and being unable to walk straight). I sat for a total of 30 minutes before I walked to my office, which is a couple minute walk. I continued to have dizzy spells (not as severe) while sitting in my office for a few more hours. Also, I'm having a hard time focusing, feel dazed.

Localized arm pain. Systemic body aches followed by severe abdominal pain, hematochezia, palpitations.

The patient became light headed and fainted two minutes after the administration of the Covid vaccine. She then slipped off the chair. Upon her assessment, no injuries were noted. After a few seconds the patient was alert and oriented. She reported having similar previous experiences with vaccine administrations. She also stated she had the White coat syndrome.

Syncope times 5 at home starting at 630 am. Called 911. Syncope 2 times at hospital. Hospitalized 2 days until it subsided. Blood pressure kept dropping and heart rate kept spiking. Had chills and aches off and on for 48 hours. orthostatic hypotension. It?s now been 5 days since being released and I?m still dizzy. Feels like I?m off balance/vertigo. Syncope has subsided but dizziness is still present.

dizziness, throat slightly closing, tongue swell, red face and neck, odd taste and drymouth, heart palpitations. This happened right when I left cvs after the 15 min, I should have went back inside. drove home and felt worried so stopped and grabbed bendaryl and spoke to a pharmacist at a Walgreens. Symptoms went away. Next day felt a little off. throat funny/tongue funny but not like the first day.

At roughly 9:00pm I was scrolling through my phone when it became very difficult to focus and I felt nauseous. I got up to go to the bathroom and became extremely dizzy and my heart felt like it was going to beat out of my chest. I was having difficulty breathing and felt disorientated. I crawled up the stairs and when I reached the top I stood up to walk and promptly fainted/passed out. According to my husband I was out for roughly 30 seconds. He described my body as completely tense (formed fists, shaking). I don't have any recollection of passing out. When I came to I was overwhelmed with nausea and immediately vomited. I was sweating profusely and struggling to breath. After I vomited, within minutes (less than three) I felt fine. My heart rate returned to normal and I wasn't dizzy or nauseous.

Anxiety Attacks, unexplained high blood pressure, elevated pulse These symptoms lasted 3 weeks from the first vaccine. I saw my doctor and just thought I was having anxiety. Started medication for anxiety. Three to four days post second shot, the side effects came back and are not yet resolved at this time. I am currently working with my doctor to determine what I need to do to lower my blood pressure and stop the anxiety attacks.

My stomach was hurting while urinating and there was blood in my urine. At another instance, there was a small blood clot.

Within 10 minutes of the 1st Moderna vaccine dose, the patient developed chest pressure, a burning sensation over the anterior chest, a sensation of mild swelling of the mouth with a metallic taste. No rash, SOB, or n/v. The patient was transported to the ED for evaluation. On ED admission, the BP=151/107, HR=76, RR=20, SpO2=96%. All labs normal (CXR, EKG, CBC, troponin). The patient declined any medications for possible allergic reactions. The symptoms resolved quickly and the patient was discharged home. Three days later, the post-ED follow-up consult found the patient was experiencing cough and congestion. She was sent for a Covid test, which came back negative.

40 YO F PRESENTED WITH A C/O OF A RACING HEART BEAT A FEW MINUTES AFTER HER VACCINATION. PT DENIES C/P OR PRESSURE. BP 150/70 HR 125 SpO2 99% @16:40 PM BP 173/142 HR 129 SpO2 99% @ 16:44 PM BP 132/78 HR 117 SpO2 100% @ 16:55 PM BP 134/95 HR 116 SpO2 99% @17:10 PM PT WAS FOUND TO HAVE PALPITATIONS AND TACHYCARDIA. HR CONTINUOUSLY FLUCTUATED DURING EVALUATION. BP WAS INITIALLY ON THE HIGH SIDE. PT WAS NOT GIVEN ANY MEDICATION, BUT ADVISED TO F/U WITH HER PCP FOR BP AND INCREASED HR. PT WAS ALSO EDUCATED ON THE IMPORTANCE OF F/U. PT VERBALIZED UNDERSTANDING. SISTER OF PT PRESENT TO MONITOR HER/DRIVE. AT 17:13, PT LEFT IN THE COMPANY OF HER SISTER. PT NOT IN APPARENT DISTRESSS.

Patient stated after she sat down she began to hear ringing in her ears and had tunnel vision; didn't remember after that; medic and this nurse ran to patient where she was laying face down. Patient began to come around and skin was pale and clammy to the touch. VS taken: HR: 82; BP: 140/70/ O2 Sat RA; 78%. Patient was speaking coherently after she woke up, was out for about 25 seconds. Patient stated she had a hx of fainting w/labs or shots. Placed cool, wet towels behind neck, forehead and lower back - patient stated it helped her feel better. VS retaken: BP: 134/66; HR: 77; O2 Sat RA: 98%. Patient sat up in a wheelchair and began to have color to face and feeling less clammy. EMT sat with patient until she was feeling better. Patient was joking and stated she felt embarrassed. Patient discharged to home. This nurse contacted her after clinic, she stated she was doing well and would be seeing us again for her 2nd Moderna dose. This nurse encouraged her to notify the next vaccinator of her hx of fainiting - She stated she would. Patient appreciative for call.

Flushing, lightheaded, sinus cleared 5 minutes after shot, extreme fatigue 2 hours after. Pain, harness, redness at injection site 6 hours after shot. Fatigue, sleepiness, floatiness , headache, palpitations, neck pain, right ear pain, 2 ulcers on left tonsil, sinus pressure lasted 3 days. Right lung/back pain upon exertion. Constipation 5 days without bm. Fatigue and palpitations linger.

Day one of vaccine approximately 6 hours after vaccination I experienced fatigue, rapid heartbeat and minor headaches. I then took 2 Aleve to relieve symptoms. Day 3 after vaccination I experienced soreness at the injection site. I did not take any pain meds for the soreness. On day 8(today) after vaccination I?m experiencing swelling and itching at injection site. My skin is also warm to the touch at the injection site. If symptoms continue I will take Benadryl to try to relieve the itching.

Symptoms began at 2200 hours on 03/01 with chills. By 0230 on the morning of 03/02, I was vomiting, had chills, had hot flashes, had motion sickness with any movement. At approximately 0230 I lost consciousness on the floor of my bathroom. My husband, witnessed this event and indicated that he saw me stop breathing for a period of about 15 seconds. I revived on my own, no intervention was needed. More vomiting, chills, and hot flashes occurred after this event. This event subsided at about 0300 hours and I was able to get some rest. I have a skin rash that developed after the vaccine but is undocumented when it began. It is still persisting today, one week after the vaccination. The symptoms of this rash are it is widespread across my torso and it is itching and has small red dots.

Day of vaccine- has increased HR within 3 mins but resolved within an hour; severe headache, lip tingling, "loopy feeling" Day after vaccine: facial swelling, daily headache, fatigue 3/7: Itchy between her breasts and bilat arm, arm pit itching, lip burning, described "spiderweb like rash with visible capillaries"; throat itchy/swelling intermittently Taken benadryl without improvement H/O asthma, allergies:

I thought my lopes were tingling immediately, but thought it may just be psychological. Several hours later, my arms and hands were tingling and numb, followed by some chest pains momentarily. Eight hires after the shot, I got up to use the restroom, in distress of the tingling and numbness. I was sitting on the toilet and seem to be going in and out of consciousness. I stood up, washed my hands... and woke up on the bathroom floor. I had clearly passed out, hit my head and lost some time.

Chest pain and back pain, nurse initially reported rash on forehead and stomach. Pharmacist went to visually inspect her forehead and stomach there was no visible rash on forehead and arm

Heart palpitations/pounding immediately, over next 48 hours-feeling like I?m going to pass out & developing hives all over body.

Pt received the vaccine on 08 March she felt tired and like her heart was racing dizzy and her face was red within 2 hours after receiving the vaccine. 1400 8 March pt left work to relax, she felt tired, sluggish and had a Headache. 09 March Pt stil felt tired, had a headache, body aches so she took the day off to rest. Pt had no fever but took Tylenol and motrin for the bodyaches. 10 Mar 2021- Pt reported to work at 0700 she still had an headache, took her blood pressure and it was 201/102, pt was transported to ED for treatment. At ED pt blood pressure was brought down 170/89, pt still had headache but was released on 10 Mar 2021. 11 March 2021: Pt reported for PCP follow up, pt still had a headache, BP was 180/120. Pt was sent to ED. Pt still had a headache Blood pressure was 169/90 pt was treated and still sent home.

Pt became dizzy, nauseated and hypertensive. Pt was placed on precautionary O2 and zofran given by EMS. Pt remained hypertensive and was transported by private vehicle to local ER.

I woke up at 1:00 am feeling like I was going to get sick. I tried to get our of bed, but was so dizzy I fell. I was unable to stand up, so I crawled to the bathroom. I couldn't catch my breath and my heart was racing. I wanted to get my phone off of the counter and call for help, but I was too confused and too dizzy to get it. I felt like I couldn't control my body. My left arm was hurting really bad during this. I am not sure if I fell asleep or laid there awake, but I couldn't get myself up and start making sense of things until 4 am. I did not have any other episodes similar to this, but I did feel really tired and weak for two days. My arm hurt really bad around injection site and through my shoulder blade for 3 days. My symptoms are all improving now. Just a slightly sore arm.

3/17/21 around 09:17 face felt hot, had hives on neck and chest , heart felt like it was racing, elevated heart rate B/P 145/117, Benadryl given and transported to emergency department at facility.

After first shot I got intermittent deep tissue numbing (not tingling) over the span of 5 days beginning about 12 hours after the injection on left side of body (injection on left arm. After the second shot (in right arm) I got tingling in right side of face about 30 min after injection. Effects weren?t bad until Sunday night when I began feeling ?odd?, deep tissue numbing in left arm, could feel my heart but didn?t feel like it was racing or pounding TOO hard, chest pains, loose stools, and when I took my BP it was high and rose to 188/??. It is usually 111/55ish. We called EMS and they gave aspirin, ekg showed PVCs (which is normal for me) and still high BP. At hospital still high. It seemed to have set off my orthostatic which usually drops but this time it was up and down. On Monday it was high 130s/80s to low 101/50s. And on Tuesday my HR kept dropping into 40s even when walking around. Wednesday I felt okay but started getting numbing late at night and just not feeling right. It is Thursday morning and I still don?t feel right.

PI: The pt is a 40 year old female who presents with syncope 20 minutes post Moderna dose #1 vaccination to the left deltoid. Pt syncopized from a seated position, falling forward and catching herself with her arms outstretched. +LOC before immediately regaining consciousness. No head or neck injury, +abrasion to the left elbow. Pt notes similar episode following an influenza vaccine 15 years ago. Pt denies any medical Hx, daily medications, or Hx of anaphylaxis. Pt denies swelling or itching of the lips, eyes, or face. She also denies any swelling of throat, difficulty breathing, or SOB. Exam (update as needed): GEN: Alert and oriented x 3 upon immediate evaluation, HEAD: NCAT EYES: PERRL, EOMI ENT: Ears normal, Nose normal, OP normal, no evidence of angioedema NECK: Supple, without LAD. CV: RRR,+Bradycardic, +hypotensive, no m/r/g PULM: Clear to auscultation bilaterally, no accessory muscle use ABD: Soft, no tenderness. SKIN: +pale, +diaphoretic, +1cm circular abrasion to left elbow, No rashea MSK: FROM, MS 5/5 NEURO: Alert and oriented x 4, CN 2-12 grossly intact, no ataxia Clinical Impression/Field Tx: Syncope post moderna does #1 vaccination. Impression supported by clinical scenario, vital signs, and Pt?s endorsement of similar incident in the past, Suspicion for anaphylaxis low due to no signs of angioedema, no SOB, and no complaints of itching. Pt also denied any Hx of anaphylaxis or allergic reaction. Vital signs stabilized in the field and pt reported improvement following 30 minutes of repositioning and observation. Because of limited resources on site, the Pt was evaluated by EMS where repeat vital signs, blood glucose, and EKG were obtained. Medications administered: None Disposition: Pt was evaluated by EMS and transported to the Hospital.

After vaccination patient reported pain in both arms and "major" headache. Increased HR; transported to ER.

Patient developed elevated heart rate to 120 beats/minute, elevated blood pressure to 180/110, elevated fasting glucose readings to 250 (normally <150), psoriasis flare and profound fatigue. All of the above symptoms developed within 48 hours of administration of the 1st vaccine and have persisted, with some improvement, for up to 9 days.

Patient stated she completed her 15 minute post vaccine observation period and "felt off". Patient went home and within one hour she felt dizzy and did not feel "right". Patient seemed confused and laid down and took her BP. BP was elevated at 156/98 and Heart rate was in the 30s. Patient contacted her cardiologist and they told her to go to the hospital. Per patient, she went to the Emergency Dept and was given IV fluids and had an Xray of her heart. She was diagnosed with bradycardia. Patient stated she feels better, but still feels tired and worn out.

Immediate spike in blood pressure and heart rate, feeling warm, very faint, lightheaded, shaky. Nurses on site were concerned about the blood pressure and heart rate and sent me to the ER in an ambulance. They monitored me there and I went home once I started feeling better with only slightly elevated pressure. For about three weeks after the injection, I felt very lightheaded, nauseous, had a headache every day, felt confused and out of it.

PtcComplained of having increased heart rate . Assessment at the time presented the this V/S B/P 146/74, HR 145, Temp 98.7, RR18 Psox 98% RA. Pt. was offered water 500 ml which she finished. She was encouraged to stay for further observation . Pt's V/S @ 12:00 was Bp 122/74, HR96, RR14, Temp 98.7, Psox 99%RAPt left @ 12:05 p mand verbalized feeling a lot better/well.

Fever of 101.0, rapid heart rate for patient (average of 69 bpm compared to 51 bpm the next night); short HRV of 26 ms (compared to 77 ms the next day); heightened respiratory rate of 20.8/min, compared to 17.8/min the next night. By Monday, March 22nd, a hard red lump had formed near the injection site. This itched and persisted until Thursday March 25th.

woke up on bathroom floor; lips tingling; soreness in the arm./painful; feel it (the arm) very heavy and hard to lift; had a tingling on arms; had numbness on arms; ears ringing; patient said it was in a lot of pain; broke in a lot of sweat; felt very weak; fell; over all fatigue; head was pounding; white blood cells were immature; A spontaneous report was received from an 40-year-old, female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced woke up on bathroom floor, lips tingling, soreness in the arm/painful, feel it (the arm) very heavy and hard to lift, had a tingling on arms, had numbness on arms, ears ringing, patient said it was in a lot of pain, broke in a lot of sweat, felt very weak, white blood cells were immature, fell, over all fatigue and head was pounding. The patient's medical history was not provided. Concomitant medications included: vitamin d nos and iron On 04-MAR-2021, the patient received first of two planned doses of mRNA-1273 (lot/batch: 013A21A) intramuscularly in the left arm for prophylaxis of COVID-19 infection. The patient reported that when she got the vaccine felt the lips tingling but thought it was psychologic. She felt soreness in the arm, but the major symptoms started within 6 hours of being vaccinated. She started to feel it (the arm) was very heavy and hard to lift. It was very painful and sore. Because of the pain and how heavy it was. Then the patient said it had a tingling and numbness on arms and hands. The patient said that progressively got worst and worst and that 8 hours after receiving the vaccine had to go to the restroom, sat on the toilet and turned to grab toilet paper and when turned back saw that already had the toilet paper. The patient said that Feel, like losing consciousness already. The patient also said she went to wash her hands and that's the last that she had remembered. The patient reported that she fell and woke up on the bathroom floor, her head was pounding, ears ringing, the patient said she was in a lot of pain, broke in a lot of sweat. The patient said that though "what if I like die because of the head". The patient stated that around 12 hours after vaccination, she went to the urgent Care. On Urgent Care the caller said that they did an ECG, Blood, and urine test, and that the only thing they mentioned was that the white blood cells were immature. The patient said that when asked about it said that could be because has received the vaccine on the same morning. The patient said that she had a headache that lasted two days, 06-MAR-2021, the headache had gone away and came back in the afternoon, and on 07-MAR-2021 headache went away and returned at evening. The patient also said that felt very weak, and an overall fatigue after the first and second day. The patient has an appointment with the doctor 19-MAR-2021. The patient had not received any treatment and had taken Excedrin PM (Non steroid anti-inflammatory) just once before the vaccine. The adverse event of woke up on bathroom floor (loss of consciousness) was assessed as medically significant. Action taken with mRNA-1273 in response to the events was not reported. Outcome of the events of woke up on bathroom floor, lips tingling, soreness in the arm/painful, feel it (the arm) very heavy and hard to lift, had a tingling on arms, had numbness on arms, ears ringing, patient said it was in a lot of pain, broke in a lot of sweat, felt very weak, white blood cells were immature, fell, over all fatigue and head was pounding was unknown.; Reporter's Comments: This case concerns a 40 Y/O F with serious unexpected loss of consciousness and nonserious unexpected paresthesia oral, pain in extremity, limb discomfort, paresthesia, hypoesthesia, tinnitus, pain, hyperhidrosis, asthenia white blood cell disorder, fall and expected headache, fatigue. Event onset Day 1 of first dose of mRNA-1273. Based on current available information and temporal association between use of the product and the start date of the event, a causal relationship cannot be excluded.

Red lesion on arm. Approx 2 inches in diameter. Started off as a pale pink. 8 days later it is bright red. Slightly elevated.

G2P0010 with EDD 4/19/2021 presented at 26-5 weeks with decreased fetal movement. COVID-19 vaccine one week prior. Noticed decreased fetal movement for 3 days. Creatinine 0.8 in first trimester with normal anatomic ultrasound. Cr increased to 1.1 on day of admission. AST 46, ALT 70, and blood pressure increased. Diagnosed with severe preeclampsia. BPP 2/10, umbilical artery Doppler AEDF, severe polyhydramnios, absent stomach, reversed a wave in ductus venosus. Fetus appropriately grown on ultrasound. Delivered via cesarean. Birthweight 840 grams (appropriate for gestational age).

12 hours after receiving the first dose, I woke in the night with extreme dizziness and subsequently fainted. I was unconscious for about 10 seconds. When I regained consciousness, I was violently ill with vomiting and diarrhea. I had chills and sweating, and extreme dizziness that felt like a hallucination. We called 911 and I was taken to the hospital in an ambulance and admitted to the hospital for treatment.

patient received the vaccine on March 20th, instantly felt sick, developed a fever. Never fully felt " Well". On March 27th her boyfriend discovered her unresponsive from Cardiac arrest, she has been on life support since. They are pulling the plug today.

Chest pain, palpitations, PAC's, short of breath, chest tightness, tingling in left shoulder/arm/little fingers, high blood pressure. 2 Emergency Room visits, admitted to hospital for monitoring.

I felt itchiness throughout my body, starting coughing and wheezing, throat felt tight and closing. I used my epi-pen and then went to the ER where I was given prednisone and antihistamines. The following day I was still having trouble breathing, tightness in my chest, wheezing, trouble walking due to not being able to breathe and symptoms persisted. I went to urgent care where I was given a prednisone booster and was sent back to the ER. ER observed me and sent me back home. I went back to urgent care and was prescribed higher dose of prednisone and singular. One week later, I still had trouble breathing, coughing, and tightness in my chest, my doctor prescribed albuterol solution with nebulized to use 4xs a day. 2 weeks later symptoms worsened when I started walking more and was prescribed another round of prednisone and continue albuterol. Currently, 7 weeks later, my asthma has not gotten better, still wheezing, coughing, unable to walk without struggling to breathe. My doctor has now referred me to a pulmonoligist.

unconscious 3 times only for a second, kind of freak out, this is like immediately everything close and her vision turned black; like vision going blurring, blurred vision with spots, very vague even when lying down, had this 25-30 times and 5 time so far; This spontaneous case was reported by a consumer and describes the occurrence of LOSS OF CONSCIOUSNESS (unconscious 3 times only for a second, kind of freak out, this is like immediately everything close and her vision turned black) in a 40-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included No adverse event (No medical history provided). On 06-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Apr-2021, the patient experienced LOSS OF CONSCIOUSNESS (unconscious 3 times only for a second, kind of freak out, this is like immediately everything close and her vision turned black) (seriousness criterion medically significant) and VISION BLURRED (like vision going blurring, blurred vision with spots, very vague even when lying down, had this 25-30 times and 5 time so far). At the time of the report, LOSS OF CONSCIOUSNESS (unconscious 3 times only for a second, kind of freak out, this is like immediately everything close and her vision turned black) and VISION BLURRED (like vision going blurring, blurred vision with spots, very vague even when lying down, had this 25-30 times and 5 time so far) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No concomitant medication was reported. No treatment information was provided. Based on the current available information which includes a temporal association between the use of the product and onset of the reported events, and excluding other etiologies, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information which includes a temporal association between the use of the product and onset of the reported events, and excluding other etiologies, a causal relationship cannot be excluded.

The patient received my second Moderna vaccine on Jan 23. On Feb 12 after they got home from work the patient noticed their Left bicep was swollen and hand was discolored. the patient elevated and iced throughout the weekend. When it did not get better by that Monday, they went to the ED. The patient was diagnosised with a Left upper arm DVT and bilat PE's. they were admitted overnight to the hospital, put on Apixaban, and have follow-up appointments.

Migraine High blood pressure Bruises Blood clot Dizziness Nauseous Fatigue Itching Chills Muscle aches

Feeling dizzy and bad; Thought her blood sugar was dropping; Lips started tingling; Started sweating; Felt weak; Felt pressure on chest; Muscles started twitching/legs started twitching; Had difficulty breathing; Anaphylaxis Shock; When the Benadryl wears off I start shaking; When the Benadryl wears off I have shallow breathing; When the Benadryl wears off throat starts tightening; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Feeling dizzy and bad), BLOOD GLUCOSE DECREASED (Thought her blood sugar was dropping), PARAESTHESIA ORAL (Lips started tingling), HYPERHIDROSIS (Started sweating), ASTHENIA (Felt weak), CHEST DISCOMFORT (Felt pressure on chest), MUSCLE TWITCHING (Muscles started twitching/legs started twitching), DYSPNOEA (Had difficulty breathing) and ANAPHYLACTIC SHOCK (Anaphylaxis Shock) in a 40-year-old female patient who received mRNA-1273 (batch no. 027B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Fruit allergy. On 15-Apr-2021, the patient received first dose of mRNA-1273 (Intramuscular) 1 dosage form. On 15-Apr-2021, the patient experienced DIZZINESS (Feeling dizzy and bad) (seriousness criteria hospitalization and life threatening), BLOOD GLUCOSE DECREASED (Thought her blood sugar was dropping) (seriousness criteria hospitalization and life threatening), PARAESTHESIA ORAL (Lips started tingling) (seriousness criteria hospitalization and life threatening), HYPERHIDROSIS (Started sweating) (seriousness criteria hospitalization and life threatening), ASTHENIA (Felt weak) (seriousness criteria hospitalization and life threatening), CHEST DISCOMFORT (Felt pressure on chest) (seriousness criteria hospitalization and life threatening), MUSCLE TWITCHING (Muscles started twitching/legs started twitching) (seriousness criteria hospitalization and life threatening), DYSPNOEA (Had difficulty breathing) (seriousness criteria hospitalization and life threatening), ANAPHYLACTIC SHOCK (Anaphylaxis Shock) (seriousness criteria hospitalization, medically significant and life threatening), TREMOR (When the Benadryl wears off I start shaking), HYPOPNOEA (When the Benadryl wears off I have shallow breathing) and THROAT TIGHTNESS (When the Benadryl wears off throat starts tightening). The patient was hospitalized from 15-Apr-2021 to 15-Apr-2021 due to ANAPHYLACTIC SHOCK, ASTHENIA, BLOOD GLUCOSE DECREASED, CHEST DISCOMFORT, DIZZINESS, DYSPNOEA, HYPERHIDROSIS, MUSCLE TWITCHING and PARAESTHESIA ORAL. On 15-Apr-2021, DIZZINESS (Feeling dizzy and bad), BLOOD GLUCOSE DECREASED (Thought her blood sugar was dropping), HYPERHIDROSIS (Started sweating), ASTHENIA (Felt weak), CHEST DISCOMFORT (Felt pressure on chest), DYSPNOEA (Had difficulty breathing) and ANAPHYLACTIC SHOCK (Anaphylaxis Shock) had resolved, MUSCLE TWITCHING (Muscles started twitching/legs started twitching) had not resolved. At the time of the report, PARAESTHESIA ORAL (Lips started tingling) had not resolved and TREMOR (When the Benadryl wears off I start shaking), HYPOPNOEA (When the Benadryl wears off I have shallow breathing) and THROAT TIGHTNESS (When the Benadryl wears off throat starts tightening) outcome was unknown. Not Provided The action taken with mRNA-1273 (Intramuscular) was unknown. The patient was treated at the closest hospital with epinephrine (epi pen), IV diphenhydramine, and IV Famotidine. The patient was having anaphylaxis shock (confirmed by Emergency Department). She stated epinephrine made her heart beat so fast that it was going to collapse. She was discharged 3 hours later from the hospital with epi pen (emergency use), diphenhydramine(as needed), Famotidine (as needed). Consumer stated that when the Benadryl weaned off she felt tingling of lips, starts shaking, muscles start twitching, throat tightening, and has shallow breathing. Company comment: Based on the information provided which includes a strong temporal association between the use of mRNA-1273 vaccine and onset of the reported events, excluding other etiologies causal relationship cannot be excluded. Anaphylaxis is consistent with the product known safety profile.; Sender's Comments: Based on the information provided which includes a strong temporal association between the use of mRNA-1273 vaccine and onset of the reported events, excluding other etiologies causal relationship cannot be excluded. Anaphylaxis is consistent with the product known safety profile.

Blood clots; Kind of bleeding; arm began being extremely itchy; This spontaneous case was reported by a consumer and describes the occurrence of THROMBOSIS (Blood clots) and HAEMORRHAGE (Kind of bleeding) in a 40-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included No adverse event (No reported medical history). On 02-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Apr-2021, after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced PRURITUS (arm began being extremely itchy). On 05-Apr-2021, the patient experienced THROMBOSIS (Blood clots) (seriousness criterion medically significant) and HAEMORRHAGE (Kind of bleeding) (seriousness criterion medically significant). At the time of the report, THROMBOSIS (Blood clots) and HAEMORRHAGE (Kind of bleeding) outcome was unknown and PRURITUS (arm began being extremely itchy) had resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In April 2021, Pregnancy test: Negative. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Concomitant product use was not provided by the reporter. Treatment information was not provided. Based on the information provided which includes a strong temporal association between the use of mRNA-1273 vaccine and onset of the reported events, excluding other etiologies causal relationship cannot be excluded; Sender's Comments: Based on the information provided which includes a strong temporal association between the use of mRNA-1273 vaccine and onset of the reported events, excluding other etiologies causal relationship cannot be excluded

severe allergic reaction to the vaccine; became incoherent, could not function; I couldn't comprehend or process what my children were saying to me, I could see their lips; Vision blurry; dizziness increased; heart was racing; 154 heart rate; woke up with a "fever"; started throwing up; face started tingling; injection site swollen; injection site with burning sensation; Covid arm; injection site hot; injection site itchy; brain fog; became dizzy, the more I moved around, the worse it would get; It like an out of body experience; I was confused; woke up with severe neck pain; neck to collarbones were swollen; low grade fever, 101.9 degrees.; ymph node in both armpits and both breast were swollen and hurt to touch; chills; extreme fatigue, had no energy at all; headache; injection site was sore to the touch, it hurt bad, but looked fine; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of ANAPHYLACTIC REACTION (severe allergic reaction to the vaccine), INCOHERENT (became incoherent, could not function), APHASIA (I couldn't comprehend or process what my children were saying to me, I could see their lips), VISION BLURRED (Vision blurry) and DIZZINESS (dizziness increased) in a 40-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included No adverse event (Medical history not provided.). On 01-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Apr-2021, the patient experienced NECK PAIN (woke up with severe neck pain), SWELLING (neck to collarbones were swollen), PYREXIA (low grade fever, 101.9 degrees.), LYMPHADENOPATHY (ymph node in both armpits and both breast were swollen and hurt to touch), CHILLS (chills), FATIGUE (extreme fatigue, had no energy at all), HEADACHE (headache) and VACCINATION SITE PAIN (injection site was sore to the touch, it hurt bad, but looked fine). On 05-Apr-2021, the patient experienced DIZZINESS (became dizzy, the more I moved around, the worse it would get), AUTOSCOPY (It like an out of body experience), CONFUSIONAL STATE (I was confused) and FEELING ABNORMAL (brain fog). On 06-Apr-2021, the patient experienced ANAPHYLACTIC REACTION (severe allergic reaction to the vaccine) (seriousness criterion hospitalization), INCOHERENT (became incoherent, could not function) (seriousness criterion hospitalization), APHASIA (I couldn't comprehend or process what my children were saying to me, I could see their lips) (seriousness criteria hospitalization and disability), VISION BLURRED (Vision blurry) (seriousness criteria hospitalization and disability), DIZZINESS (dizziness increased) (seriousness criterion hospitalization), VACCINATION SITE REACTION (Covid arm), VACCINATION SITE WARMTH (injection site hot), VACCINATION SITE PRURITUS (injection site itchy), VACCINATION SITE PAIN (injection site with burning sensation) and VACCINATION SITE SWELLING (injection site swollen). On 11-Apr-2021, the patient experienced PARAESTHESIA (face started tingling). On 11-Apr-2021 at 1:15 AM, the patient experienced TACHYCARDIA (heart was racing; 154 heart rate), PYREXIA (woke up with a "fever") and VOMITING (started throwing up). The patient was hospitalized from 06-Apr-2021 to 10-Apr-2021 due to ANAPHYLACTIC REACTION, APHASIA, DIZZINESS, INCOHERENT and VISION BLURRED. At the time of the report, ANAPHYLACTIC REACTION (severe allergic reaction to the vaccine), INCOHERENT (became incoherent, could not function), APHASIA (I couldn't comprehend or process what my children were saying to me, I could see their lips), DIZZINESS (dizziness increased), NECK PAIN (woke up with severe neck pain), SWELLING (neck to collarbones were swollen), DIZZINESS (became dizzy, the more I moved around, the worse it would get), AUTOSCOPY (It like an out of body experience), CONFUSIONAL STATE (I was confused), TACHYCARDIA (heart was racing; 154 heart rate), FEELING ABNORMAL (brain fog), VACCINATION SITE REACTION (Covid arm), VACCINATION SITE WARMTH (injection site hot), VACCINATION SITE PRURITUS (injection site itchy), LYMPHADENOPATHY (ymph node in both armpits and both breast were swollen and hurt to touch), CHILLS (chills), FATIGUE (extreme fatigue, had no energy at all), HEADACHE (headache), VACCINATION SITE PAIN (injection site with burning sensation), VACCINATION SITE PAIN (injection site was sore to the touch, it hurt bad, but looked fine), VACCINATION SITE SWELLING (injection site swollen), PYREXIA (woke up with a "fever") and VOMITING (started throwing up) outcome was unknown, VISION BLURRED (Vision blurry) and PYREXIA (low grade fever, 101.9 degrees.) had resolved and PARAESTHESIA (face started tingling) had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 02-Apr-2021, Body temperature: 101.9 (High) 101.9 degrees. On 11-Apr-2021, Heart rate: 154 (High) 154. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Concomitant product use was not provided. The patient was taken to the emergency room on 06-Apr-2021 and was then hospitalized. Treatment details included hydroxyzine and IV (intravenous) steroids, and dexamethasone as well as IV fluids. The patient was advised by her HCP (health care provider) to not take the second dose of the vaccine due to having an allergic reaction. On 10-Apr-2021, the patient was released from the hospital but her injection site was sore, swollen and getting bigger. The patient reported additional side effects on 11-Apr-2021 that are ongoing. Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Reporter did not allow further contact; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.

Fainted twice and couldn?t maintain consciousness. I woke to urinate and went from feeling a little ill to burning up and unable to move off the ground or move my limbs. I became nauseous and dizzy. I fainted on the bathroom floor and again a little while later when I tried to crawl to my purse for the thermometer. After I laid on the floor for a while, I regained enough energy and to make it back to the bathroom with an intense urge to defecate. (I almost pooped my pants while passed out.) But, it wasn?t diarrhea consistency It was blackish, but normal consistency. At some point I took 2 Tylenol and fell asleep in the floor. By 2:30am, I was feeling strong enough to climb back into bed. I felt like I was dying but then it was over pretty quickly and I was back to feeling normal flu symptoms; 102 fever, body aches, etc.

Passed out; Right arm became norm down to her fingers; No longer move right arm from elbow down to fingers / lost functioning completely in the entire right arm; Terrible pain in the entire right arm; Heart rate dropped; Vomited; This spontaneous case was reported by an other health care professional (subsequently medically confirmed) and describes the occurrence of LOSS OF CONSCIOUSNESS (Passed out) in a 40-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 039K20A and 031L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No medical history was reported. Concomitant products included LEVOCETIRIZINE DIHYDROCHLORIDE (XYZAL) for an unknown indication. On 04-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 05-Jan-2021, the patient experienced LOSS OF CONSCIOUSNESS (Passed out) (seriousness criterion medically significant), HYPOAESTHESIA (Right arm became norm down to her fingers), HYPOKINESIA (No longer move right arm from elbow down to fingers / lost functioning completely in the entire right arm), PAIN IN EXTREMITY (Terrible pain in the entire right arm), HEART RATE DECREASED (Heart rate dropped) and VOMITING (Vomited). At the time of the report, LOSS OF CONSCIOUSNESS (Passed out), HYPOAESTHESIA (Right arm became norm down to her fingers), HYPOKINESIA (No longer move right arm from elbow down to fingers / lost functioning completely in the entire right arm), PAIN IN EXTREMITY (Terrible pain in the entire right arm), HEART RATE DECREASED (Heart rate dropped) and VOMITING (Vomited) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Electromyogram: unknown (Inconclusive) result unknown. On an unknown date, Heart rate: low (Low) Drop in heart rate was reported. On an unknown date, Spinal X-ray: normal (normal) Reported to be normal. mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. Treatment details included the use of ibuprofen and oral steroid prednisone. A week later the patient's arm was still very painful and some functioning had returned but not up to 50%. Company comment: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded. This case was linked to MOD21-083933 (E2B Linked Report).; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded. MOD21-083933:2nd dose

Vaccine was given at 10:30 am on 12/29/20. The injection caused mild discomfort at the site (right deltoid) followed by swelling, redness, warmth, and soreness. The swelling, redness, warmth, and tenderness to touch worsened by 24 hours, peaked at 48 hours, and has since improved (but continued well over 120 hours post vaccination). Other than the arm discomfort, I felt well the rest of the first day however I woke at 1:30 am (15 hours post-vaccine) with severe muscle cramps in my lower legs and feet. I was freezing and had significant chills. PJs, a robe, and 3 blankets weren?t cutting it. I took Ibuprofen 600 mg and a robaxin 750 mg because the cramps were severe and unrelenting. Tmax was 100.5. Sleep was poor and intermittent. I got out of bed around 24 hours post vaccination and was extremely nauseous and weak. I took Zofran 4 mg and Tylenol 500mg and laid around the rest of the day. I forced some food down at hour 29 (had not eaten in 20-21 hours). My eyes and the injection site were itchy prompting me to take Benadryl 25 mg at hour 22. I got a second round of shaking chills, nausea, and worsened myalgias at hour 32. I also felt as though the injection site pain migrated towards my right axilla. Took a second dose of Ibuprofen 400 mg, Zofran 4 mg, and robaxin 750 mg and fell asleep by 7:30 pm (unheard of for me). When I woke to go to work at 6:30 am (44 hours post vaccine) I was still very achey and fatigued. My right axilla was very sore and tender to touch, moreso than the injection site. This same discomfort migrated to the right side of my neck and behind my right ear (which was worse by hour 55 and brought on a headache). Thank goodness it was a short shift due to the holiday! While caffeine and a third dose of ibuprofen and Zofran help me through the 6.5 hour shift I was still not myself. The fatigue and achiness did not let up until a little after 96 hours. I really didn?t feel like myself until day 5 (118 hours post vaccination) and the injection site and my right axilla are still sore and tender to touch. There is still redness and occasional itchiness at the injection site. I took my usual doses of Advair and Claritin despite the nausea all 5 days. I should also mention, that while on shift (hour 48-ish), I felt a very brief, unprovoked heaviness in my chest similar to the sensation I felt after I recovered from COVID in March. Sensation lasted seconds and came a few times throughout the day. No SOB, diaphoresis, or wheezing. That same discomfort started 2.5 weeks after I was diagnosis with COVID and about 5 days after feeling "fully recovered" from the fever, body ache, fatigue and nausea I had experienced with COVID. That chest sensation would come and go with decreased frequency over 6 weeks post COVID. I?ve had a total of 5 episodes of the chest heaviness but none today (day 5). I wonder if that?s what will happen with the vaccine. I also wonder if the side effects I?m feeling have anything to do with having had COVID 9 months ago. My husband and other ED colleagues who did not have COVID had no side effects with the first dose of the vaccine but the few colleagues that had COVID all had some degree of an adverse reaction to the vaccine. I never want to feel as bad as I did in March but I?m dreading my second dose of the vaccine. Is it recommended in my case? I should also mention, I had an adverse reaction to the pneumonia vaccine 1.5 years ago - arm blew up, no respiratory symptoms. Needed Benadryl and Prednisone. I?ve had a MMR booster and flu shot since with no adverse reaction. Not sure if it is relevant.

Left sore arm at site 48 hours, dizzy, headaches, fast heart rate average 104-115 x 2 days, 3-5 days headaches and neck ache, neck stiffness, neck pain

First Headache at approx 10:00pm then later that night at approx 02:00 am left armpit pain, left upper chest pain, left humerus pain, left elbow pain, left wrist pain, left radius and ulna pain, fatigue, lethargy, insomnia, fever 99.9 was highest taken with 2 extra strength Tylenol taken, chills, excessive sweating, decreased appetite until evening of the next day. arm pain decreased but arm pit remains swollen and painful for 2 days so far. Headache gone after 36 hours.

?Moderna COVID- 19 Vaccine EUA? Flu vaccine allergy discussed at length with patient prior to Moderna vaccine. Patient's arm became red and very swollen on two separate occasions after receiving flu vaccine but patient did NOT experience difficulty breathing, respiratory distress, throat swelling, shortness of breath, or anaphylaxis. Approximately 11 minutes after receiving Moderna vaccine, patient complained of warmth and redness at injection site. Immediately after this complaint, patient began to faint and complain of difficulty breathing and pain when breathing. Rapid response was called. Patient continued to complain of painful inspirations and difficulty breathing. EpiPen, albuterol inhaler, and diphenhydramine IM were administered. Patient improved and was transported to emergency room for further monitoring. Patient improved in emergency room and was discharged sooner after.

1845 PATIENT REPORTS HEART PALPITATIONS, FLUSHED FACE, FEELING WARM, ICE PACK TO NECK, FEELING NAUSEATED. 1848 BP 161/114 HR 112. 1852 BP 148/91 HR 92 PATIENT RESTING. 1900-1910 PATIENT FEELS LIKE SHES "HAVING A DRY THROAT, "A LITTLE SHORT OF BREATH, AND TIGHT IN CHEST." BP 144/95 HR 84 SAO2 99%. ICE PACK TO NECK. PT OFFERED H20 AND JUICE. RELAXING WITH EYES CLOSED.1920-1928 BP156/97 100% PATIENT FEELING ANXIOUS. DEEP BREATHING. 1938-1949 PATIENT MOVED TO QUIET AREA UNDER OBSERVATION. BP 138/93 HR 81 SAO2 99%, FEELING BETTER, NO NAUSEA, SCRATCHY THROAT IMPROVING, DENIES SEVERE ANXIETY. 1959 PATIENT FEELING BETTER, NO RASH, THROAT TIGHTNESS OR ANXIETY, VSS, CHEST TIGHT BUT BETTER, PATIENT REPORTS SIMILIAR TO BASELINE. PATIENT STABLE WANTING TO GO HOME. AWARE OF NEEDING TO SEEK MEDICAL CARE THROUGH ER OR HER PROVIDER IF SYMPTOMS WORSEN.

Recipient reported chest tightness, throat closing up, tachycardia, feeling flush approximately 2 minutes after vaccine administration. B/P- 162/76, HR- 124, O2 sat. 100%. She was taken to our outpatient clinic for close monitoring. Some symptoms were resolving. She reported right and then left arm numbness with a heavy feeling in her left eye. She remained in the outpatient department for monitoring until approximately 3p last set of vital signs B/P- 109/72, HR- 16, O2 sat. 100%

Recipient reported symptoms of chest tightness, throat closing up, tachycardia and feeling flush approximately 2 minutes after the vaccine administration. She was taken to our outpatient clinic for continued observation. Vital signs: B/P 162/76, HR-124, O2- 100% she had relief of some symptoms but also reported right then left arm numbness and heaviness of the left eye. She was monitored for until approximately 3p. Last set of vital signs: B/P 10/72, HR- 81, O2- 100%.

3 Days after the covid vaccine. I Started to have these symptoms around 1am: fever, chills, body aches, cold sweats. I took ibuprofen fell asleep. Around 330am. Woke up with dizziness, headache, chills. Took tylenol. Fell asleep body was extremely cold esp hands and feet. Woke up around 7am. Still had severe body aches and was extremely dizzy, headache worsening. Took ibuprofen. Woke up around noon. Extremely dizzy with chills and body aches headache still severe. Took tylenol. I was not getting better. went to hospital . It was found I had extremely high wbc and had extremely low blood pressure. Diagnosed as septic shock.

Original soreness at injection site lasted 2 days and resolved. On day 7, the shoulder (not arm) became tender with blanching erythema. Currently self-monitoring distribution of erythema at home with marked boundaries on skin.

Shortly after vaccination, client felt slight tightness in the chest and shortness of breath. Approximately 5 minutes after vaccination, client began having tingling in the right arm (same arm as vaccination). Tingling spread to head and neck area and client began to feel warm. O2 saturations were 100%. Pulse was normal. Client had a general feeling of "unwell". Client was monitored for 30 minutes after vaccination. Symptoms were stable, and client was sent home with husband. Instructions given to client to watch for worsening symptoms and call their healthcare provider if symptoms worsen.

Estimated due date: 02/07/2021. Will probably be induced a week earlier. I felt mild pain in my arm in the evening of the 31st and then the pain started from my elbow to my neck on my right side. I went to sleep and woke up with general malaise, chills, body ache, sore throat, headache. the same feeling I had when I had covid, a heaviness in my chest, almost like a shortness of breathe. I was flushed and felt feverish although I never had a fever. The symptoms lasted all day. On the first also my arm pain was severe, I could not even lift it the whole day. I went to sleep on 01/01 and when I woke up on 01/02 the symptoms were all gone. I took Tylenol 3 times to help me with the symptoms. 3 grams total in 24 hrs.

Patient had history of feeling dizzy/faint from needle pokes. She thought she'd be alright- but 5 minutes after the vaccine, she got very pale and lightheaded. Staff eased her onto the floor (she did not faint or lose consciousness) and staff raised her feet up on a chair. Then after about 5 minutes on the floor, we had her sit up and helped her to a cot- continued to lay down another 15 minutes. She also had not eaten or had anything to drink yet that day (she was vaccinated at 11:15am). Given apple juice, which also helped her body recover. No injury was sustained.

states had sudden onset flushing from chest to head, increased pounding heart rate, difficulty swallowing, tightness, numbness in throat, extreme anxiety, approximately 45 minutes after vaccine lasted 5-10 minutes, however the swallowing issue lasted 2-3 hours States did not seek medical treatment, symptoms resolved on their own

first dose of Moderna COVID vaccine. within a five minutes, had tachycardia, relative hypertensive syndrome. no wheezing or hives or itching. no anaphalaxis symptoms. Patient was observed and discharged to home. doing well. In an attempt to determine mechanism of the reaction we are ordering serum and urine catacholamines and serotonin studies results are pending. we have seen at least three others with a similar hyperdynamic tachycardia with relative hypertension immediately following the first dose of Moderna COVID vaccination.

I received the injection around 2:15 pm. There were no immediate effects. By late afternoon/early evening, my arm was a bit sore and later started to feel warm near the injection site. However, I otherwise felt fine. At 9 pm, I suddenly became very dizzy and passed out for several minutes. When I regained consciousness, I felt a little short of breath, which resolved within 20 minutes or so. However, I was also extremely nauseous, which got worse any time I tried to move. This continued for several hours. I also alternated between being very warm and chills during this time - it was like waves of heat. I did not have a fever. Later, my head began to hurt and I took tylenol to help with that. I also had diarrhea. These symptoms began to gradually lessen after a couple of hours and I was able to fall asleep around 12:30 pm. I woke up hot and sweaty several times throughout the night. The following day, 1/6, I was very tired and had a headache and could not eat much, but otherwise felt much better.

Fever, Tachycardia, CHILLS Narrative: PULSE WAS 115 FOR ABOUT 3 HOURS. TOOK TYLENOL AND NO FEVER, CHILLS OR HIGH PULSE NEXT MORNING

I woke up from sleep with severe chest pain at approx. 0400. It was sharp and radiated up to the left side of my neck. The pain was worse with breathing whether I was sitting up or lying down. My heart rate was 150 initially, but came down to 110's after a few minutes of waking up. My heart rate did not decrease with rest and the chest pain was not going away, so I drove to the emergency room to be checked. Before I left the house I used my albuterol inhaler once to see if it would make the chest pain and tightness any better. I received an EKG, mylanta mixed with lidocaine, IV pepcid and IV torodol to help relive the pain. The pain eased some (was a 8/10 when I awoke to a 2/10 after treatment). My blood was drawn, a chest x-ray was taken and the provider informed me all of my lab results, chest x-ray, and physical examination was normal. My EKG showed tachycardia and my heartrate did not drop below 100 beats per minute throughout the whole ER visit. My BP at the highest was 151/94. I have never had a problem with a fast heartrate or high blood pressure in the past. I was discharged with a diagnosis of pleurisy caused by a cough I have been having. I spent the rest of the day with chest pain and left arm pain from the site of the vaccination.

Within minutes rapid onset feeling of facial and neck flushing + rapid heartbeat + increased resp rate + shaking. Lasted approx 2 minutes. Subsided then returned a few minutes later for approx. 20 to 30 seconds then subsided. Left facility with no treatment. Onset of swollen tongue evidenced by scalloping approx. 1.5 to 2 hours after.

EXACTLY 15 MINUTES AFTER THE VACCINE ADMINISTRATION WHEN I FELT LIKE MY THROAT IS CLOSING UP LIKE I CAN'T SWALLOW THEN I FELT MY HR IS BEATING FAST THEN MY FEET AND MY LEFT SIDE OF THE BODY FELT COLD. THAT'S WHEN I RAISED MY HAND AND CALLED FOR HELP. THEY IMMEDIATELY CAME AND ASSESSED ME. THEY PUT MY HEAD DOWN, GAVE ME 02 WITH 2L/MIN AND WET TOWEL ON MY FOREHEAD. THE INITAL BP WAS ABOUT 158/90 111 PER THE MCS. AFTER 20-30 MINUTES OF MONITORING MY SYMPTOMS STARTED TO GET BETTER, THEY TRIED TO SIT ME UP SO I CAN TAKE BENADRYL BUT I FELT DIZZY. SO THEY PUT BACK MY HEAD DOWN AND CALLED 911. TOOK 50 MG OF BENADRYL AND LATER SENT HOME BY PARAMEDICS.

Patient presented with blotchy skin and tightness in the chest. Blood pressure was 190/110. Patient was given some oxygen and blood pressure had decreased. Patient blood pressure was still high and complaining of chest tightness.

I was sitting in observation at minute 10 or 11. All of the sudden I felt as though my heart was racing, I developed numbness and tingling of both my arms as well as my legs. I then develop tingling and numbness of my face. I felt dizzy and as though I was going to pass out. I then sought help

Patient reports seconds after receiving the vaccine she felt a strange sensation in her chest which she has a difficulty characterizing but describes as "a strange sensation". Vitals at that time demonstrated tachycardia and hypertension which she was referred to the ED for further evaluation. She does admit that she has anxiety and felt this may be contributing to the symptoms. She reports she is already starting to feel improved. She is noted to have some redness over her left ear and feels it is a little warm but no other rash. She denies any associated shortness of breath, dizziness or lightheadedness, arm or jaw pain, associated nausea, vomiting, back pain, lip or tongue swelling. No fevers, chills, or cough. Patient was given one dose of diphenhydramine 50 mg PO Once and monitored in the emergency room. Symptoms completely resolved and was hemodynamically stable. Patient discharged home from the emergency room.

Began with a sore arm at injection site then could not lift arm higher than four inches without excruciating pain, muscles throughout body began to tense up and hurt, joints and hips ached and hurt, headache all over the top of my head, sweat then chills, tired, light headed, nauseated, temperature topping 103 degrees

Few minutes after injection - unusual taste in the mouth and sense of palpitation About 8 hours after - rash on the back of both hands, not itchy, lacy faint rash rapidly spreading limited to the hands, associated with tingling and paresthesia on both palms.

Feeling fine in morning. Had cup of tea, went for vaccine at 10AM. Did fine with injection, sat down for observation, 8-10 minutes later started feeling sweaty, then passed out. Woke up on the floor with nurses around me feeling tightness in chest, numbness in fingers, body shaking off and on, started to feel like tongue was swelling. Nurses gave IV fluids, oxygen and 2 Epi-Pens. Transported by ambulance to Buffalo General Hospital. Symptoms resolved not long after arrival at hospital. Remained in EMT bay hallway for observation., seen there by ER doctor. Another EGK done, additional half bag of IV fluids, released after 4 hours observation.

Warm sensation in chest 10 minutes after receiving vaccine, tight feeling in face 30 minutes after vaccine, tingling numbness in face 1 hour after vaccine, warm and tingly feeling down back between shoulder blades 1 hour 30 minutes after vaccine, ears felt warm and ringing 3 hours after vaccine, cool tingly feeling on entire back 8 hrs after vaccine.

Scratchy throat, pressure & tightness in chest, headache, malaise, nausea, cramping(gastrointestinal pain), diarrhea, migraine, extreme exhaustion, fatigue, muscle and joint pains, cold flashes, extreme weakness, off balance, feeling faint

I received the vaccine at 12:59 pm and at 1:05 pm my heart began to beat rapidly. I felt heat rush into the left side of my head, I was extremely light headed and couldn?t catch my breath. I asked if there was a nurse that could help me. There was 1 paramedic watching everyone. I stepped outside, took my mask off to catch my breath. One staff member accompanied me and sat next to me. I began to shake in my legs and arms involuntarily, my heart kept beating and I just tried to do deep breathing techniques to catch my breath. The paramedic came outside and asked if I wanted help. I declined his help and I called my husband who was sitting in the car to help me walk to our car. At 1:15, my heart was beating less rapid, I walked back to the car and as my husband was driving us home, my heart began to beat rapidly again, I felt burning and heat in my head and I began to shake in my arms and legs. It lasted about 10-15 minutes. We got home and I could barely walk into the house because I was so weak in my legs. I went to bed where my heart began beating back to normal after 1 hour or so.

Pt complained of chest pressure and no other symptoms. Pt stated she had same symptom the day befor. Vital signs taken and were within normal limits. 127/79, p 78, SaO2 100%, conferred with Anesthesia, Pt to ED for evaluation.

Patient given Moderna vaccine 1455. Patient reported feeling numb tongue, dizzy and nauseous. Patient took 25 mg diphenhydramine oral. Observed at vaccine clinic. began feeling more nausea. Tongue numbness not improving, took another 25 mg diphenhydramine. Patient sent to ED - taken by PALS/RN. Arrived in ED at 1600 complaining complaining of chest tightness with tingling in her throat. Out of concern that she may have progression to anaphylaxis so 0.3 mg of epinephrine was ordered intramuscularly. Patient also given 25 mg of Benadryl IV as well as Pepcid and Solu-Medrol. Patient was observed here in the emergency department for several hours. She did have some complain of some itchiness of her skin so additional 25 mg of Benadryl was given. She also was having some persistent chest tightness and appeared quite anxious and due to concern for anxiety is possibly a contributing factor, IV Valium was given for anxiolysis. On reevaluation, symptoms have improved significantly. She was counseled in regards to use of an EpiPen and a prescription was given for this. Prescription was also given per few days of prednisone and Pepcid. Provider recommended avoiding further covid19 vaccination.

She felt dizzy immediately upon standing. She has a hx of SVT with cardiac ablation in Feb 2020. No medications noted. Experienced rapid heart beat within 10 minutes with dizziness and shortness of breath. Complained of chest pain, Rapid response team called. Per team - NSR, vital signs stable. Taken to ER for further evaluation.

I had my first COVID 19 Moderna vaccine Lot: 025J20-2A at hospital. Within about 60 seconds of receiving it, my heart started pounding hard and rapidly and I let a nurse know. She took my vitals and my heart rate was very high, as was my blood pressure. My O2 was fine. I had some tightness and heaviness I my chest. I felt flush in my cheeks, but did not have hives. The nurse said my color was very pale. I was warm, given an ice pack, and then a bit later cold. At one point they wanted me to go to the Emergency Department, which I refused (perhaps stupidly). I'm not sure I was thinking clearly. I was trying very hard to stay calm and relaxed. My blood pressure was very elevated for about an hour and a half. They finally let me go home when I was 140/95 (my usual is 110 over 70 ish). I had some tongue tingling at home, very briefly.

Right at the 15 minute mark I developed a full body sense of warmth followed by tremors and my HR rose from 70 to 138 very rapidly. My mom was on the phone with me and stated I didn?t quite know what I was saying to her and she became worried. The RN came by asking how I felt and I told her I was jittery and decided to wait at the site a few more minutes. The sensation passed after about 3-4 minutes and then I felt ok. I drove home and showered. The rest of the night I would get random bouts of tachycardia and felt overall not well. Also a small amount of chest tightness. I also noticed things such as climbing by stairs cause me to become winded very fast and my HR would elevate rapidly. Today I woke up and am feeling almost normal. HR has not been elevated but when I ate I did notice a small amount of lightheadedness.

The first 10 hours I did not have any symptoms. That night about 12 hours later, I experienced headache and arm swelling at the injection site. At 3 am that morning , I had 102. fever. By the time fever broke, my arm had a goose egg the size of an actual egg. The fever continued off and on the next 24 hours. The next day, my arm was swelling more about the size of a lemon. My whole arm was swelling. I then called my ER doctor. It felt like a hard lump. The fever I had again 102.3. I took Tylenol and Motrin and could not break fever. My heart rate went up to 125 from the fever. The next day, I felt achy, chills, nausea and then they subsided. It took about a week for the arm swelling to resolve.

Woke up 3:45am because rolled over on very sore arm, stood up and felt nauseated, blacked out, dizzy, chills, couldn?t get warm, sweating. Headache by 8am, no fever. Body aches.

Pt stated a few hours after injection, she had difficulty swallowing , hear palpitations and felt light headed

At time of shot fast heart rate monitored by the facility no other symptoms Next day headache, sore injection site, swollen lymph nodes arm pit and neck on side of injection, extreme fatigue slept all day, chills, vomiting (2x), muscle aches Following days low grade fever on and off, fatigue, intermittent fast heart rate, chills fatigue Today day 6 much improved mild fatigue

Immediately after vaccine pt experienced chest tightening and tingling to arms and hands. This has persisted on and off until current.

Anaphylaxis- throat tightness , nausea , rash , pruritis , chest tightness, wheezing . 9-11 called epinephrine x 2 , decade on , IV Benadryl , duo-nebs, famotidine, admission to icu high dose prednisone , nebulizers , zofran , duo-neb nebulizers

Moderna covid 19 vaccine EUA 10 minutes post vaccine administration I experienced severe nausea, vomiting and loss of consciousness temporarily. I did not require an epi pen but did require anti histamines

A day after the shot I was in the shower and started experiencing exhaustion and shortness of breath. I also had tachycardia. I proceeded not to feel well they?re very next day. Then on Friday I was dizzy and a coworker said that I was flushed and I wasn?t feeling well. I proceeded to go see patients and while examining a patient I became very dizzy and lightheaded while bent over and almost passed out when I came up.. at that time I decided to leave work and go to my PCP. Orthostatic?s were positive and EKG showed normal sinus rhythm and an echo is ordered. Echo was normal. Throughout the week I continued to have tachycardia and shortness of breath with any type of exertion. I left work this morning and was tested for Covid because of my symptoms.

The evening of the vaccination, I experienced rapid heart rate but only for a minute or less. The following day, I was fatigued and had arm pain. A few days later, the injection site was itchy and warm to touch. This lasted until day 8.

Approx 15 min after vaccine administration, patient had a vasovagal and near-syncopal event - felt dizzy and flushed, became pale and diaphoretic, low BP (88/62), low HR (45). Quickly recovered after being laid supine. Was brought to urgent care for continued monitoring and evaluation where she continued to improve and was discharged in stable condition and feeling baseline at approximately 15:30.

Injection given IM in patient's L deltoid. EUA distributed to patient per CDC regulations. Lot # 011J20A Manufactured by Moderna Patient filled out COVID 19 Immunization Screening and Consent Form. Pt presented to clinic 1/9/2021 for first dose of Moderna COVID-19 vaccine. 10-12 mins post vaccine pt began to feel warm/dizzy. Pt experienced a brief episode of syncope, shortly after pt regained consciousness , and then experienced 1 episode of emesis Pt was alert, reported hx of vasovagal type sx's, She was given juice, took Midodrine, and given IV Sodium Chloride 0.9% VSS Pt then reported feeling fast heart rate, EKG done w/ NSR Pt began to experience body tremors, HR 109, BP WNL EpiPen administered at 10:58 a.m. per provider's order Pt reports subjective tongue swelling , Second dose of Epi given 11:08a.m. Pt transported to Hospital via ambulance

Within 1 minute of vaccination administration patient complained of extreme dizziness and was noted with increased blood pressure. Approximately 20 minutes later, complained of nausea. Symptoms resolved approximately 40 minutes later.

About 10 minutes after the shot, my chest felt very hot and spread to both my left and right arm down to my elbows. Simultaneously, I experienced a weird taste in my mouth that was not metallic. My heart rate increased. I sought help immediately. My chest was a bit painful. That subsided a bit and then both arms felt tingly from my elbows to my wrists. That subsided and came back, milder each time. This lasted for about 50 minutes before I was allowed to leave and go home. I am typing this 7 hours later and my tongue feels a bit swollen (not unusual based on my food allergies and am not concerned to go to the hospital), and my chest still hurts a bit. I am wondering if it's anxiety at this point. My breathing and speaking have been totally fine. I got home with no trouble. I rested for several hours just to make sure I did not overexert myself.

Saturday 1/9/21 I felt fine all day, until approximately 6:15 pm when I suddenly felt light-headed, dizzy, increased heart rate, palpitations, feeling of tight throat, disconnect between what I was saying and how I was hearing my own voice, difficulty expressing my thoughts, headache, shortness of breath. The following day I continued having some dizziness, headache, nausea, shortness of breath. Mon. 1/11-Thurs. 1/14 I had splitting headaches and nausea. I developed a rash on my arm at the site of the injection at some point, unsure when. The rash wasn't noticed until Sunday 1/17 and still remains today, 1/18.

Raised heart rate 168-203 bpm dizzy numbness lips tongue face flushed skin lasted approximately 45 minutes Severe headache for 48 hrs occasional lightheadedness is still present Monitored by nurse and dr on site for 2 hrs reclined on floor

Patient was vaccinated and within 10 minutes bilateral hands started swelling, chest tightness as well. Patient took 100mg benadryl po and within 15 minutes swelling decreased. Speaking with patient at 1654 patient denies any symptoms and hand swelling and chest tightness are completely gone.

Patient was vaccinated and within 10 minutes bilateral hands became swollen with chest tightness. Patient was given 100mg benadryl po and within 15 minutes her symptoms diminished. at 1700 when speaking with patient she denies any symptoms.

Did have chills, body aches, joint pains, fever 101.5, pain into left shoulder blade, and lightheaded. Heart rate increased from 125 to 140 (not within 15 min of vaccination during monitoring period). Symptoms lasted 36 hrs.

Moderna COVID-19 vaccine EUA 1-14-21 migraine lasting 4 hours (patient has no Hx of migraines) 1-14-21 and daily through and including date of reporting 1-20-21 Intermittent Dizziness mild to severe/near fainting, unable to recreate with canal repositioning techniques. Tested for OHTN with no significant statistical alteration in BP readings. Dizziness presents similar to stepping off of a boat. Comes and goes in waves. Has happened daily usually beginning around 1-2pm and lasting through bedtime.

Within first 15 min my throat started to feel like it was closing up. My tongue also felt like it going towards the back of my throat and I was dizzy/lightheaded. It lasted. About 5/7 min. It felt like was easing up so the school nurse told me wait an additional 15 min to be sure I was ok. She also took my blood pressure and said was normal. Dr. a pharmacist brought me orange juice a d said maybe was just low blood sugar. I said it felt similar to when my epidural during last delivery was up too high and my throat closed up and I couldn?t breathe. About ten min later it began again. I tried to get up and walk around some and I felt a little better at first but then started to get significantly worse. I felt like I was struggling to breathe and tongue was swollen feeling and stuck to back of mouth as if it was paralyzed. I say back down and my blood pressure was high (just told bottom number was 106). I was moved to another room to lie down and pharmacist mentioned using epi pen or benedryl shot. I had to sit up and almost passed out. I was having difficulty breathing. Not because of my lungs but my throat and tongue seemed frozen. He decided to give me a 25 mg Benadryl shot but had me drink it. It had a horrible bitter taste and made my throat and tongue numb. At this point it was about 12:30. My administrator called a coworker to drive me home. I decided to leave about 29 min after I had the benedryl. I could still feel that my throat was somewhat tight but it had improved enough that I didn?t think I was in danger of not being to breathe again. I went home (15 min drive) and by then my throat felt a lot tighter. I took 25 mg more of benedryl and it felt better. About four hours later it became tight again and I took 50 mg of benedryl. Through out all this I had severe pain at site of injection in my left arm, dizziness, nausea, and headache.

After receiving my first dose of the moderna vaccine I felt my heart begin to flutter for several minutes. I lost feeling on the left side of my face and my tongue became numb. The symptoms remained for well over five hours until I took two Benadryl. Then the symptoms subsided. I have had a terrible reaction to the drug Compazine in the past which resulted in loss of motor control in my face. While I never lost control of my motor functioning after receiving the vaccine, the loss of feeling in my face was similar to my past reaction to Compazine.

On 12-26-2020, I woke up feeling weak, very dizzy and dragged down. I felt generalized malaise, headaches, body aches,. I worked a 12 hour shift, was pale. I had alot of more weakness through my body and was very nauseated and had loss of appetite. On 12-29-2020, I felt a heaviness to my chest, extreme pain with rapid heart beat, I had elevated blood pressure, had numbness to my face and hands (pins and needle sensation) . The day after 12-30-2020 I was seen lower extremity weakness and visible muscle spasms in my knees and legs. I had a hard time ambulating and I was weak for another week. I had shortness of breath and had difficulty going up the stairs. I went home that same day when they ruled out it was not a cardiac event.

On evening of dose, experienced arm swelling, hardness, and redness. Fatigues, chills, fever, nausea, and muscles aches started day after till 3 days after. Those symptoms started on Friday, but then on Friday started to feel dizzy, with vasodilation and tachycardia. Felt like was going to pass out. - lasting an multiple hours. Felt tachycardia (measured by Fitbit) which started Friday evening and has lasted to this day of reporting. Tachycardia is slowly improving.

Started with coughing/chest tightness minutes after getting the shot. Then started to have a pressure feeling on face and head. Was given 50 mg of benedryl by nursing staff. Also experienced nausea and a general feeling of not feeling well.

Vaccine was received in the left deltoid. First symptom was right arm going numb at about 10 minutes. At about 25 minutes had full body severe itch. At 35 to 40 minutes had sudden onset of chest pain, tachycardia, shortness of breath, and hypertension. I had pre-medicated with Benadryl and Pepcid. No further interventions were needed. Symptoms resolve spontaneously about 30 minutes later.

Patient stated they felt hazy, and had chest pain 3/10, has asthma history. Used inhaled and after ~15 minutes patient stated he felt better and was discharged.

Approximately 5-6 minutes after receiving the injection, I felt palpitations and my heart racing. I thought it was anxiety due to receiving the vaccine (though I had never had symptoms like that ever before), so I started deep breathing to try to calm down. It continued to worsen but then stopped after approximately 2 - 3 minutes after deep breathing. I did not check my pulse during the episode but it felt like a regular rhythm, just elevated rate. No medical attention or treatment was needed. My heart rate was elevated for approximately 20-30 minutes afterwards (around 100bpm; my baseline is in the 70s). During the episode, it felt much higher than 100bpm. I have had no further symptoms since then.

Patient become dizzy and overall not feeling well, patient was placed supine and hooked up to a pulse oximetry. Oxygen saturations were WNL but heart rate tachy, was placed on telemetry which showed tachycardia 160-180, blood pressure elevated, patient was anxious and to note was also nervous/anxious about receiving vaccination prior to injection. Patient was then transferred to the ER to be evaluated by MD. At that time EKG completed with NSR 94, BP 133/85, 100 % oxygen on room air, respirations - 20. Dizziness and tachycardia subsided within 20 minutes without intervention, patient continued to be anxious regarding event.

Moderna Covid-19 Vaccine EUA Chills, joint pain, headache, palpitations (ekg from Watch showed PVC's- I am Cardiology nurse) that lasted approx 12 hours

Pt received vaccine and was cleared for discharge after 15 minute evaluation. Pt left clinic site and saw a friend and sat down to speak to this person for a few minutes. During this interaction, the pt began to feel unwell and apparently fainted. The nurse gave oxygen and alerted EMS. Vital signs were assessed and were stable; the pt regained alertness rapidly prior to her disposition by ambulance for emergency evaluation.

Febrile throughout the night. Chills when I woke up in the AM. Suddenly felt dizzy and lightheaded. Sat down, had a few sips of juice and placed a cold rag on my neck. With assistance, agreed to move to the couch. Stood up and went limp. Guided down to the floor. Per report, body shuttered initially. +LOC for 5-10 seconds.

9:45pm- approx 12 hours after injection I got chills and uncontrollable shaking, lips turned purple, it lasted overnight. Severe exhaustion and headache and Chest tightness occurred which lasted for 36 hours post injection.

Immediate full body heat rush and heart racing upon injection. Right arm went numb down to elbow, numbness then radiated up to neck & side of face into ear, up back of head, back toward shoulder blade and then down lateral torso. Numbness turned into intense pins and needles with intermittent jolts the day after the vaccine and slowly began to diminish. Most intense first 5 days, and lasted in a significant manner a little over 2 weeks. Now is barely noticeable shoulder blade and side of neck. Chest tightness nearly immediately after vaccine. Used albuterol inhaler 30 minutes after vaccine which helped. Chest tightness reappeared 6 hours later, took Benadryl and inhaler. Required inhaler in the evening for 2 more days following vaccine. Diarrhea began day after vaccine, lasted 2 days Neck muscles felt too weak to hold up head, began shortly after vaccine and recurred each afternoon for about 5 days. Day 11 developed a sudden rash/redness with heat and swelling over the injection site. Took Benadryl and called PCP when rash worsened the next day. Visit to PCP 13 days post vaccine due to rash. MD unsure if allergy or infection, recommended antibiotics, but by day 14 after taking Benadryl for 3 days, the rash dissipated without beginning any antibiotics.

Second Vaccine Issue 1/19/2021 Vaccine admin 1015am – Left Gluteal. 1/20/2021 AM fatigue and low back ache. Some swelling and discomfort at injection site. No Redness. 1200 Increased fatigue and general malaise 1430 Onset of nausea and headache 1445 Vasospasm of hands due to Raynaud's and Sjogrens. Chills and shivering 1515 Fever 99.8. Vasospasm continued. Joint aching and generalized pain 1545 Vasospasm resolved. Ibuprofen 600mg. Vasospasm lasted 1 hour 15 min. 1745 Fever 100.1. Tylenol 1000mg. Joint pain and back pain increased. 1845 Fever 102.7 2100 Temp 100.0 2200 Temp 99.0. Joint pain and back pain decreased.

Taste of vaccine after 10 minutes immediately following increased heart rate. Alerted staff and was taken to room for observation, BP check. BP 200/ 100 and heart rate increased (baseline BP 130/85). Throat felt numb and scratchy. Given diphenhydramine and BP checked after 15 minutes with noted decline. After 45 minutes was released. Ongoing symptoms of throat discomfort and periodic heart palpitations over next 4 days. Self- treated with propranolol used for anxiety and diphenhydramine. Reported effects to neurologist after day 4. Fully recovered after day 7 post-vaccination.

After 15 min I walked to my car. In car felt NUMB LIPS, FAST HEARTRATE, over the next 3 hours I felt EXTREME DIZZINESS, LIGHTHEADED , CONFUSION, THROAT SWELLING, NAUSEA, FOGGINESS, FLUSHED, WEAKNESS and TIRED. I felt like I might die, yet I couldnt do anything to get help because I was out of it. At the first signs I sent my Doctor a message that said "Got my shot today. Have extreme dizxziness., fast heart rae,, num blips, fogginess. Lump in throat . Is this normal feel hotl? They sent me back a phone number for covid. I called the number and asked for help, they told me the symptoms of the covid shot, not the reaction. They did not offer help.

At 1410 patient stated they felt their heart beating fast, BP= 171/93, HR= 188, O2 Sats RA= 100%, Temp= 36; at 1420: BP= 152/100, HR= 82, O2 Sats RA= 100%, at 1430: BP= 142/87, HR= 80, O2 Sats RA= 100%. At approximately 1430 patient stated she felt fine and left the facility.

Initial reaction: within minutes of vaccine lightheaded, slowed reaction time, hypertension (178/95), dizziness, stayed in clinic x1 hour until symptoms improved. water/OJ. Fatigue began that afternoon. Took 400mg ibuprofen before bed. At 3am the next morning, severe chills, fever, severe muscle and joint aches, vomit x1, Continued ibuprofen 400mg q6h until vomiting, then could not medicate. Symptoms continued, including fever 100.5-101.5, and lightheadness with ringing in the ears and black tunnel vision when standing throughout the day. Dizziness resolved that evening but chills and cold sweat, joint pain continued. Some diarrhea day 3. Today, continued sensation of mental fogginess and fatigue.

The patient woke up Saturday (1/23/21) with a sore arm and also woke up a little late (for her) with a headache. The patient also felt like she wanted to throw up. The patient went to the bathroom, then started seeing light spots. Shortly after the patient went to the floor. Her husband said that she had a seizure. Said she went stiff, arms were pinned down, eyes open and fixed for 20-30 seconds. and then went limp and sweaty. When she came to, she was nauseated and weak. She took Zofran and slept most of the day. She woke up Sunday and felt fine.

5 minutes after my body begin to feel warm and I begin to get light headed and my upper brow began to swell. I was laid down and my BP and BS wd elevated so I was take to the ED where I was given benedryl, pepcid and tylenol . I was released with a Epi pen and while at home my tongue starting feeling a little furry and swole a little but I continued to take benedryl for that but I had a bad headache that lingered for the next 2 weeks after wards

Within less than 10 minutes of receiving the vaccine I began to feel a tingling sensation inside my mouth. That moved to my lips within the following 10 minutes and my pulse increased. I received benadryl at the triage area of the vaccination clinic and monitored. My BP was unusually high (140/90). In the days that followed, the injection side was swollen and raised, the muscle around it knotted, and incredibly painful. I had some slight symptoms such as headache and nausea. Those all subsided by Friday, 1/22/2021. One week later (today, 1/26/2021) the injection sight is suddenly reinflammed; the knot has returned and is larger than before, the skin is raised and red and hot to the touch, and it is extremely itchy. I was advised at the vaccination clinic that I would be able to receive the second dose, but that I should take benadryl prior to receiving it. Now I'm wondering if I should receive it at all. Why should it be reinflammed, a week later?

Patient received her Vaccination today. She reported dizziness and foggy head feeling and felt like her BP was high at 0520 pm. She has h/o HTN which is controlled as per pt with medication as noted in her records. Pt has taken her BP today as well. Pt denied headache, nausea, vomiting, abdominal pain, rash, shortness of breath, chest pain, dysphagia, wheezing. Pt was monitored for over 30 mins given her recorded allergies in past VS checked at 0520 pm:BP: 129/76 HR: 76 sats : 100% VS checked at 0535 pm: BP: 121/72 Hr: 73 sats : 100% Pt remained stable and reported that her sx have improved and left in stable condition at 0535 pm.ER precautions given to pt - if her sx worsen or new sx start which were discussed with her she will need to go to nearest ER or call 911.

1427 - Patient states feels dizzy and nauseated. Via w/c transported to private observation area. EMT on site in attendance. BP 95/70; HR 56; RR 20; O2 98% on room air. Color pale. Offered water and drank without difficulty. No vomiting. Denies throat discomfort, itching, headache. Continued to rest. Patient's fiance in car waiting. 1433 - BP 120/86; HR 83: RR 20: O2 99 % on room air, no SOB noted. 1436 - EMT offered an ambulance for further evaluation. Patient refuses. States she felt much better and did not want to go to the hospital. Color improved, pink. Taken to personal vehicle via w/c. Advised not to drive to allow fiance to drive.

Vaccine at 9 am 1-15-21, by 7 pm experiencing fatigue, chills, sweats for the next 24 hours. 1-17-21 at 2am woken up by itching, covered in rash/hives from head to toe, took benadryl. Severe headaches began and continued until around the 25th, treated with tylenol and ibuprofen with little relief. Morning of 1-18-21 developed thrush and treated with nystatin. Noted increased fluid retention and swelling, rash still present. From the 17th to 21st noted a 10lb weight gain due to fluid, rash present until 21st, swelling continued to increase. Noted increased SOB, and chest pressure, went to ER at 9pm 1-23-21 when at #28lb weight gain was noted. Sx began to subside over the next few days with weight slowly coming off.

pt states she woke up w/ dry heaving, dehydration, fast heart rate , sweating and headache. Pt went to ER and called her PCP today. Her symptoms have subsided with the exception of fast hear rate.

patient hand numbness and tingling to hands and feet, complaints of feeling warmth throughout entire body, felt weak an faint. Heart racing and just did not feel right. was observed for 1-1/12 hours. Upon driving home and getting home, throat felt a bit full, had chills, was shaking, felt feverish. Less than 24 hours later was very achy, flu like, and arm felt dead.

About 36 hours later had tachycardia - heart rate of around 140 that awoke me. Called 911, ekg was normal, bp normal, heart rate came down. Followed up with bloodwork at urgent care that day. On 1/21 or 1/22 heart rate in 140s again - went to primary care doctor, ER 3 times over next several days. Tachycardia happened frequently during day, usually accompanied with nausea. Saw cardiologist on 1/25 and obtained 24 hr monitor- preliminary diagnosis is SVT.

Shortneas of breathe. Headache. Dizziness. Heaviness in chest. Exhaustion. Rescue inhaler, Tylenol, water, rest

On Jan 28th at approximately 4 am I woke up with severe body aches, a fever of 101.2, severe fatigue, chest pains, headache, nausea, chills. I have slept the entire day, unable to get up. And of course the arm where the injection was administered feels like lead.

Pt. Was seen for covid-19 vaccination on 1/13/21. She presented to observation at 12:29pm for her 15 minute observation. Between 12:34-12:38pm pt. Endorsed sudden onset of dizziness and chills. I called for RN assistance who obtained VS and I began clinical assessment. Pt. Denied CP, SOB, DOE, difficulty swallowing was reported. She was able to speak in full sentences, no audible wheezing, facial swelling, one sided weakness or difficulty with speech production. On exam: breath sounds clear, pt. diaphoretic, cool to touch, visible pallor. She denies prior allergic rxn to vaccinations, denies daily medication. Reports medical hx including Sjögren's syndrome and psoriasis. She reports eating breakfast (meal&juice) prior to vaccine administration. Denies allergies to food or medications. 12:40pm: BP 60/49, pulse 81, 02 sat 100%, RR 16. Repeat BP 60/33, rapid response (code blue) was called. Pt assisted transferred to clinical reclining chair, placed in supine reclining position, fluids started (500 bolus NS),FS glucose 93, and EMS called. Patient remained a&o x3, no syncope. 12:46-12:50pm: reported onset of stiffening of hands and l/e. below the knee. AROM remained intact in extremities. Approximately 12:56pm EMS arrived, EKG WNL (per EMS), patient able to ambulate with assistance from reclining chair to EMS transport chair. Approximately 12:58pm BP 93/47. Pt. was stabilized in DTMO following 500 mL NS, BP 92/54 prior to departure to ED at 1:05pm. RN contacted pt. Emergency contact (as documented in RN note) with EMS arrival and prior to ED departure. Pt. Belongings were collected, including cellular phone, and placed in patient belonging bag and given to patient prior to her departure. RN will follow up with patient tomorrow and schedule in office follow up. PCP notified per rapid response report.

Chest tightness and cough starting 20min after injection. Got better as day went on. 9pm body aches and chills started. Fever 101.6. Lasted 36 hours. Also severe body aches, severe headache. Had to call out of work 2 days in a row. Severe headache and back ache still present 48hrs after vaccine. Still breaking out in a cold sweat.

Shot 1 given Dec 29 in the morning. I had no symptoms. I got very sick at about 4:30pm Symptoms: muscle aches, chills, fever, headache, SOB, chest pain, sore throat, cough. I ended in the ED because I couldn?t manage my asthma and my HR was high on Wed. I was diagnosed with Covid as I found out my husband gave it to me. Then a couple days later my asthma got worse and I ended up in the ED overnight. They were able to get better management in my Asthma. I was sick for 3 weeks. Went back to work week four 1/25 Monday and 1/27 they cleared me to get the second dosage of the vaccine. I got the vaccine 3:20 pm and at 5:00 I walked my son in Kung Fu and then waited in my car. I ended up passing out in my car at approx 5:15 pm and my 8 year old son knew something was wrong and had to wake me up. I could barely drive home I felt very drunk. When I got home my temp spikes to 101.3. I had extreme muscle pain, fatigue, chills, sore throat, chest pain, cough, SOB. My left arm swelled up where I was injected and I couldn?t move my arm. I was told I couldn?t take anything tylonel or Ibuprofen for 8 hours. I suffered. Even when I could take something my body was very painful. This lasted wed, thurs, and Friday morning.

48 hours after vaccine I had an episode of SVT lasting approximately 30+ minutes. Paramedics were called and they decided to take me to emergency room via ambulance due to 180 pulse lasting approximately 30+ minutes.

The next day of vaccine on 1/10/2021 in the afternoon I started feeling very fatigue & taquicardia my heart rate was in the 90s. On 1/11/2021 I couldn't do anything I stayed home I still had fatigue but I also had a server headache. The fatigue went away by 1/12/2021 but I still had a headache it felt like a pressure headache & that went away until 1/16/2021.

morning after first Vaccine dose started early menstruation, exhaustion, HA, myalgias, arthralgias without fever; + nausea and lack of appetite without v/d- lasted ~48-72 hrs - rash started 1/21 on LT upper arm at previous injection site - redness, swelling and warmth; + itchy and tender; can't lay on LT side due to pain; with some chest heaviness

AFTER INJECTION, PATIENT DESCRIBED FEELING NOT QUITE RIGHT, EXPLAINED AS A "FOGGY" FEELING. PATIENT STAYED SEATED AND BLOOD PRESSURE WAS TAKEN. SYSTOLIC BP IN 160'S, PATIENT IS TYPICALLY NORMOTENSIVE. PATIENT DESCRIBED A TIGHTNESS/HEAVYNESS IN THE CHEST AND THAT LEFT ARM WAS SORE. PATIENT WAS MONITORED FOR APPROXIMATELY 40 MINUTES TOTAL. TOWARDS END OF OBSERVATION, PATIENT STATED SHE WAS FEELING BETTER. NOT DIZZY AND NO C/O CHEST DISCOMFORT. I PERSONALLY CHECKED ON PATIENT APPROX. 4.5 HOURS AFTER VACCINATION, PATIENT STATED SHE FELT FINE WITH NO COMPLAINTS OTHER THAN A SORE ARM. INSTRUCTED PATIENT TO FOLLOW UP WITH HEALTHCARE PROVIDER IF ANY ADDITIONAL SYMPTOMS PRESENT.

Around 10am today I started having chest tightness and pain, some shortness of breath. It was constant and every time I got up to walk around my BPM (on my Fitbit) went up to about 120. I am normally around 70 and even when sitting still it was 80-95. I went to urgent care around 1 and saw Dr. They checked my blood pressure several times and it was between 118-126/84 (normal for me is about 105/70). They did a PCR test for COVID but later called to tell me the sample was mislabeled. In the meantime I went to a rapid testing site and got an antigen test that was negative. Dr opinion was that the reaction was most likely an immune response to the vaccine. He said I should go in if symptoms last longer than 1-2 more days or if they get worse. They said I could repeat the PCR test if I needed to be seen again but felt pretty confident about the antigen test results. I am still having the same symptoms tonight, the same severity. I have no other symptoms of COVID and did not have any other vaccine side effects besides expected/mild ones. I had a little shortness of breath last night before bed but the chest pain didn?t start until today. I?ve gotten all scheduled vaccines throughout my life plus some for travel and have never had a reaction. I have never had anything like this chest pain and have no history of heart issues.

Severe headache during the day after vaccine given. Then around midnight , woke up with extreme chills, body aches, weakness, nausea.. Got up to go to bathroom to throw up, at this time my husband was with me and when I got to bathroom, I passed out. He was holding me, stated my eyes were open and pupils very dilated. He had to wake me out if it (maybe just under 1 min) When I woke up, I vomited a little. Then until about 4 am I continued to have extreme chills, body aches and threw up a few more times. Still currently (9:30 am) feeling very weak and have a bad headache .

I woke up on Saturday AM, the night after receiving the vaccine, and I passed out while walking back to bed.

Employee started having palpitations, shaking , dizziness, anxiety and hypertension about 15 minutes after administration of vaccine. Employee was admitted to the ED

On 1/30/2021, I developed a mild headache followed by an acute change in my vision. I went to the emergency room 24 hours later after the symptoms had not resolved and was found to have a left superior quadrantanopia and a 2.3cm x 1.9cm hemorrhage in my right occipital lobe. I was admitted to hopsital and discharged today 2/3/2021. My headache has resolved but I continue to have a visual field deficit. I had been scheduled to receive the second dose of Moderna on 2/1/2021 but was unable to receive it due to my hospitalization.

Patient reported feeling the same chest tightness that she felt with the first dose of Moderna vaccine. She said it was hard to swallow, but was not experiencing shortness of breath. Monitored patient and symptoms did not worsen, so patient elected to leave after the 15 minute observation period.

Will call back later this week with lot number. Two days later my body started tingling, I ended up leaving work early. I called the doctor who said and take some Benadryl and rest it off. I was nausea all weekend and slept most of the weekend. I went to work on Monday and worked through Thursday. Friday 1/22/2021 afternoon my body began tingling again, I became so weak that I couldn't walk. I had to leave work early and they made my husband come pick up because the staff at my job did not think I was safe to drive. I was nauseous again. I had major diarrhea and vomiting about a week after receiving the vaccine. This lasted around 3 days. I finally went into the ER on 1/24/2021. They treated me Magnesium and Potassium and 2 bags of IV fluid and said I was dehydrated and sent me home. I went from the ER and I could not sleep that night, the ER gave me so much Zofran it was just to much. I still continued to throw up at home. Went back to ER this time in on 1/25/2021 around 5AM I was losing feeling in my fingers and toes, they were completely numb. I was also still vomiting. They said I my electrolytes were still out of balance and gave more nausea medicine, medicine to help with the cramping and more IV fluids. I was sent home later that afternoon. I went to work on the 26th, I felt slow to react, trouble concentrating, very lethargic, and off balance. I was still nauseous but it was getting better with medicine. My eyes yellows turn straight yellow, I thought I had jaundice. I was able to work all day. I left work and when I pulled into driveway at home 7:01 PM and EMS was in front of my house 7:14 PM. I went inside and went to bathroom and my husband found me and I was having a full blown seizure, foaming at the mouth. EMS took my to ER and I was treated for a seizure and an elbow injury and went home. I have seen the neurologist and my physician since being discharged. They did more blood work. I have been having high blood pressure since then. I am trying to get an MRI scheduled that my neurologist ordered. They started Keppra 500 MG to control the seizures. I have been taking Tizanadine for muscle spams from the elbow injury when I feel during the seizure. I did have an MRI 6 months ago.

approximately 5-6 minutes after receiving her first Moderna covid19 dose, this patient began to feel weak, dizzy and felt tingling in leg. Questioning about symptoms revealed she had no other symptoms at first. A blood pressure check revealed blood pressure was 186/100. She was feeling anxious and said her heart was racing. I asked patient what her blood pressure usually runs to which she responded she did not know. I asked her is she was feeling fine and she said she felt like she was having trouble swallowing. With her consent I gave her a glass of water and 5ml of diphenhydramine 12.5mg/5ml. Checked blood pressure again and it was 200/118. Throughout the process I asked patient about cutaneous, respiratory, gastrointestinal symptoms. She reported no itching; her face showed no swelling or pallor--I had asked her to pull her mask down three times to check for redness, swelling. There was none. Some minutes into the episode she reported that she felt much better. I asked her to stay seated for 10-15 minutes to make sure she was feeling fine. After 15 minutes she told me she felt fine and was ready to leave

Within 12 hours of receiving vaccine I began to feel fatigue in my muscles and a mild headache. The next morning I experienced brain fog, inability to formulate thoughts correctly, difficulty thinking, lack of concentration, muscle soreness, aches all over body, tired easily, shortness of breath, fever, chills, and nausea. 36 hours after receiving vaccine, I still feel uneasy on my feet, light headedness, muscle soreness, stiff neck, nose bleeds, headache, nausea and extreme fatigue.

Dizzy immediately following vaccine, then high blood pressure, funny feeling in mouth and some difficulty easily swallowing, sweating

pt stated she experienced dizziness, heart racing, numbing and tingling of the tongue and arms. Pt BP and Pulse were measured, and showed elevated. We tried to get her breath and stay calm. Paramedics was called to assist. Vitals improved after paramedics arrived

10 min after second dose vaccine, she felt tightness in her chest. Patient has history of Asthma and self medication with albuterol inhaler. O2 Sats, BP and Pulse all normal through observation period. Patient was observed for an additional 30 min. No further need of albuterol and left with chest clear with no wheezing

arm pain started than my heart rate elevated. Resting heart rate was in the 90's but could go all the way up as high as 130. Bad stomach pain, reflux, body aches, headache, fever upwards of 101.2 and nausea. elevated heart rate most concerning. Same side effects were observed with the first one but it did not start for 5 days after the shot and lasted about a week. This time the doctor gave me an ARB to take which calmed down the side effects.

Patient felt extremely lightheaded, nervous, experienced syncope approximately five minutes after administration.

Fever (103), nausea, tachycardia (130 resting HR), muscle aches, headache All resolved after 48 hours

The patient received dose 1 of the COVID Moderna vaccine at around 7:00 AM on 2/8/21 at her place of work The patient came back to the vaccine area around 10:00 AM saying she was experiencing shortness of breath, jaw pain, tingling in her left arm, and chest tightness. Her blood pressure was 188/120 mmHg at 10:05 AM with a heart rate of 105 bpm. The patient said she had had a heart attack a year prior. We called 911 at around 10:12 AM. EMS arrived and took a manual blood pressure of 178/118 mmHg, and took the patient to the hospital shortly after.

Right after I was administered the vaccine, I felt my heart beating fast and slight dizziness. I think it took about a good hour for it to subside. After wards I was left with extreme exhaustion. The next day my arm was sore and the exhaustion continued. The baby of my head was also hurting so I took Tylenol. Within 48 hours of the vaccine, all symptoms subsided including the sore arm.

Racing heart, nervousness, severe fatigue, chills, body aches, fever of 101.6, headache, loss of appetite,

8 days after my first vaccine my arm was red, swollen, fevered and spread to cover a large area of my arm. I started to itch on the left side of my neck and around my lip/mouth area. I also felt my heart beat faster and heart fluttering or skipping a beat. This lasted 4-5 days.

Received 2nd dose of Moderna COVID-19 vaccine on Fri. 1/22/2021 at 13:00. By 19:00 that evening, I started to feel hot and my body started to ache. Then the chills and headache started shortly after, along with a rapid heart rate followed by bouts of fatigue. It intensified overnight and continued all day Sat. 1/23. I took Tylenol and Advil to relieve some pain and reduce the fever, but it didn't help much and I just stayed in bed. It was difficult to get up. On Sun. 1/24, I could finally manage to get up without help, but felt dizzy and weak. I continued to take Tylenol to reduce my fever. At it's peak, it was 102.5 and it stayed between 101.5 - 102.5 from Friday night until Sunday morning. Then it started to range from 100.5 - 101.3 for most of the day Sun. 1/24. By Mon. 1/25, I could tolerate the aches and pains, but still had a fever for most of the day. I stopped taking Tylenol to see if my fever would finally break and it did by that Mon. 1/25 night. I returned to work on Tues. 1/26. I woke up symptom free finally.

Fast Heart Rate lasted about 5 minutes after injection Light headed lasted about 15 minutes after injection Dizzy lasted about 5 minutes after injection

After receiving the vaccination I had tingling in my left arm. I had a rapid heartbeat with skipped beats that took a long time to subside. Saturday and Sunday they would come in spurts. Medication was taken to help. It helped some, however the skipped beats and the rapid heart rate continued. By Monday, the 8th my heart rate was back to normal.

As I was leaving the clinic, roughly 20 minutes after receiving the vaccine, I because very nauseous and returned to tell the nurse I didn't feel well. I then had an episode of syncope and was unconscious for around 40 seconds. I was transported to the hospital via ambulance. In the ambulance I had a second syncopal episode while the EKG monitored that my HR dropped to 30 bpm. I was unconscious the 2nd time for around 1 minute. Upon arrival to the ER I vomited uncontrollably for a few minutes. For the last 3 weeks following the vaccine I've had a fever of 99.8, headaches, mild diarrhea and nausea. For 10 days following the vaccine I had trouble with thinking clearly and "brain fog". Beginning 2 days post-vaccination my left supraclavicular lymph nodes became very swollen and hard and have remained that way since.

Right arm started with small amount of redness 9 days after infection. It started to get bigger and splotchy, area was raised and hot. Flushed, hot face and mild tachycardia.

After the first shot, tiredness and lethargy started in 17-18 hrs post vaccine. Fever recorded at hone ear thermometer 20 hrs post vaccine 101.5. Lasted about 2 days. Motrin Tylenol round the click for 24 hrs. I also took Motrin right after my shot, still had moderate arm pain or soreness at the site. After the second shot, I took Motrin with in the hour. Fever lethargy, exhaustion started within 10 hrs post vaccine. Tachycardia for an hour , severe chills and fatigue. Took Motrin and rested . Insomnia followed. Next day was similar low grade fever and extreme tiredness. 2nd day was better. 3rd day had lethargy all other symptoms resolved . Only slight soreness at infection site remains.

41 year old female received Moderna vaccine on 1/8/2021 (lot 011J20A) and 2/4/2021(lot 011 L20A) . About 2 days post vaccination noted small red spots on her tongue, arms and legs. On 6 days post vaccination she noticed a red mark on her neck and had prolonged epistaxis. She had a normal hemocue in the clinic and normal vital signs with no further bleeding. She was sent to the Emergency Department via chartered flight. In the ED she was noted to have a petechial rash of mucous membranes, upper and lower extremities and multiple ecchymosis. Her platelet count was 2. Hemoglobin 13.3, hematocrit 40.2%, WBC 7.86. Metabolic panel unremarkable, coagulation studies unremarkable. Vital signs normal. After consultation with hematology, Dr., she was given high dose steroids and tranexamic acid and sent via medevac to MC for possible IV Ig and platelet transfusion. She arrived there sometime early this morning. Platelets were 4 upon arrival at Medical Center.

After the vaccine was given which was at 5:45 pm and it passed 15 minutes of waiting time, I start it getting dizzy, drowsy, my heart accelerated, anxious. I told the nurse on stand by, what I was feeling and she said to seat down because she was going to check my blood pressure. She checked by BP and it was on 160/80's ranges, was checked 3 times and they were the same ranges. I don't suffer from high blood pressure I told her. So she gave me cranberry juice and water and I stayed for another 30-45 minutes. She rechecked my BP and it went down to 138/70's. I was told if I want it to go to the ER to get check, I told her that I felt much better that the dizziness went away and my accelerated heart had lessen. I feel much better today and BP it's back to normal ranges.

2/4/21-chills, fever, abdominal pain, body aches, sore arm; 2/8/21-asthma flare up, chest pain and tightness, rash on legs, bruised injection site.

12:30 am 2/11/2021; fever, chills, all over body aches, severe fatigue, sharp pains from injection site down arm, legs, across chest and face. Lasted until approximately 5 am on 2/12/2021. 2/12/2021 at 6am; Foginess, forgetfulness, light headedness, still ongoing but resolving. Tylenol and ibuprofen for treatment-effective except for the forgetfulnees/foggy feeling

epistaxis one day after and two days after. Also with one episode of rectal bleeding the day after. CBC, PT and PTT were all normal.

Within 12 hours was having trouble breathing heart pounding thought I could just rest and could not it was so bad went to the ER on 2/14/21 @ 8:30 am my O2 was at 87 dropped to 81 BP was 158/101

The patient received her 1st dose Moderna on 2/6/21. On 2/7/21, the patient reports that she began "shaking, chills, numbness all over, headache, and felt as though she may pass out.' She sought care via a visit on 2/11 where she described heart palpitations. She was referred to the Emergency Department on 2/11/21. On arrival, her chief complaints were "shaky, dizzy, intermittent heart palpitations, some shortness of breath at times, headache, and body aches." Labs and vitals normal. EKG showed a right bundle branch block with nonspecific ST changes (Twave inversion V1V2). No prior EKG for comparison. Normal troponin, d-dimer = 0.29. Overall clinical impression per ED: (1) heart palpitations, (2) fatigue following covid-19 vaccine, (3) shortness of breath, (4) Right bundle branch block.' She was discharged to home with instructions to follow-up with her PCP. A post-discharge phone call on 2/12 confirmed patient was feeling well and only reported 'dizzy' as an ongoing symptom. The only medication intervention in the ED was one dose of ketorolac for body aches.

Thrombocytopenia. Platelets went from 175K day of vaccine to 56K four days later. Petechiae on feet and legs morning after vaccine. Additionally, cold sweats overnight. Woke up with headache, body aches and extreme fatigue, as well as injection site soreness.

Cold and clammy; Fever of 104 F; Injection site pain; Headache; Muscle pain; Chills; Joint Pain; Fatigue; Nausea; Hallucinations; Tachycardia; Felt Unwell; A spontaneous report was received from a healthcare professional, concerning a 41-year-old, female patient, who received Moderna's COVID-19 vaccine and experienced hallucinations, injection site pain, headache, muscle pain (arthralgia), chills, joint pain, fever of 104 F (pyrexia) with fatigue, nausea, felt unwell (malaise), tachycardia and felt cold and clammy. The patient's medical history was not provided. No relevant concomitant medications were reported. The patient received their first of two planned doses of mRNA-1273 (Lot number: unknown) unknown route of administration on unknown date. On 05 Feb 2021 at 10:00 am prior to the onset of the events, patient received their second of two planned doses of mRNA-1273 (Lot number: 028L20A) intramuscularly for prophylaxis of COVID-19 infection. On 05 Feb 2021, approximately at 18:00 patient developed injection site pain, headache, muscle pain, chills, joint pain, fever of 104 F with hallucinations, fatigue, nausea, felt unwell, tachycardia and felt cold and clammy. On 08 Feb 2021, patient was cold and clammy and heart rate was 110-120 bpm. Patient treated symptoms at home. No treatment information was provided. Consent for safety follow up was given. The patient received both scheduled dose of mRNA-1273; therefore, action taken with the drug in response to the event is not applicable. The outcome of the event, experienced injection site pain, headache, chills, joint pain, fever of 104 F with hallucinations, fatigue, nausea, felt unwell, tachycardia and felt cold and clammy were unknown. On 08 Feb 2021, The event, muscle pain considered resolved.; Reporter's Comments: This case concerns a 41 year old, female patient, who experienced a serious unexpected event of Hallucination after receiving second dose of mRNA-1273. Very limited information regarding this event has been provided at this time. Further information has been requested.

Hypertrophic Cardiomyopathy; Chest Pain; Chest Pressure; Numbness in Left Arm; Back Pain; A spontaneous report was received from a nurse concerning herself, a 41-years-old, female patient who experienced hypertrophic cardiomyopathy, chest pain, chest pressure, numbness in left arm, and back pain. The patient's medical history was not provided. concomitant medications included metoprolol, omeprazole and acetylsalicylic acid. On 21 Jan 2021, approximately four days prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 [Lot number 0412L0A] intramuscularly in the for prophylaxis of COVID-19 infection. On 25 Jan 2021, four days after the vaccine administration, the patient started experiencing chest pain, chest pressure, numbness in left arm, back pain and hypertrophic cardiomyopathy and was hospitalized in emergency room for 48 hours from 25 Jan 2021 to 26 Jan 2021. The event hypertrophic cardiomyopathy was also considered to be medically significant. Treatment information was not provided. Action taken with mRNA-1273 in response to the events were not provided. The outcome of the events chest pain, chest pressure, numbness in left arm, back pain and hypertrophic cardiomyopathy were considered unknown at the time of this report.; Reporter's Comments: Very limited information regarding this events has been provided at this time. Further information has been requested.

Face swelling, severe congestion, tightness of lungs. Body ache. Going on 4 weeks of this. 2 er visits

5 minutes after injection I experienced tingling all over, nausea, sweating, dizziness and racing heart rate. It lasted for about 2 minutes and gradually subsided over next 5 minutes. Soreness in arm is only symptom 3 hours post injection. I did not notify health department staff because it subsided.

20 minutes after the shot my heart rate went up. 25 minutes after the shot there was chest tightness, similar to when having an angioadema/allergic reaction. 25mg of Benadryl was taken and things calmed down. Since then there have been hives that have been slowly getting worse. Prior to the shot, the chronic hives were under control.

Patient reported Shortness of breath and that she almost passed out after walking up the stairs. She reported fluctuation of heart rate for about an hour, heart rate went up to 119 then drastically dropped to 36 then up to 147 then back to 119.

I had extreme pain in my arm. I couldn't even lift it. It caused my blood pressure to go up. I called the Dr. and Dr. gave me an extra dose of my BP medicine and put me on Ibuprofen. And told me to keep taking these until I started to feel better. It took 2-3 days for pain to go away and for me to get back to normal.

I felt a little lightheaded after the first shot on 1/28/21, they had me stay an additional 15" and I felt ok. After the 2nd shot on 2/25, I immediately felt a little lightheaded, sat for 15", when I stood up to leave I felt lightheaded and had to sit down. The staff member got me a cup of juice and some water. I stayed for another 15", I felt better, a little kind of "flighty" feeling but not like I did when I had to sit. I went home and did ok. I dont think i drank enough fluids that evening. That night around midnight I had chills and could not sleep, muscle aches, headache. Around 8 am when I woke up to go to the bathroom, I felt so lightheaded that I had to lay back down, my temp was 100.4. I drank some water. I got back up to take tylenol and get more to drink. I still felt lightheaded and fatigue, temp was down to 99.6. I drank 3 bottles of water and a gatorade before I needed to urinate. I dont know if the lightheaded feelings were a drop in blood pressure and the more intense lightheadedness the next day after the 2nd shot was a presyncopal episode. I continued to nap and drink fluids until about 2p when I woke up I no longer felt lightheaded and the fatigue was getting better. I still had a headache til that night. I did call Occupational Health to go over my symptoms, they told me to push fluids and rest. Today I emailed my doctor, PCP to go over things and see if he thinks this was a reaction to the vaccine vs not drinking enough the night before, I am leaning toward a reaction since it made me feel weird right after the shot for both times. As of Saturday 2/27 AM I am feeling more like myself, still drinking alot and resting though.

Patient received Moderna Covid 19 vaccine lot# 031L20A exp date 07/22/2021 0.5ml to left deltoid at 10:15 a.m. 02/12/2021. Patient was asked to wait in parking area for monitoring of adverse reaction. At approximately 10:20 a.m. officer called to nurse that patient was not feeling well. RN and LPN went to assess patient at her vehicle. Patients lips were blue pallor color and she stated that she "just felt weird and a little short of breath". No rash or swelling. Patient reports that she did not feel her throat was swelling. RN applied ambu bag to patient appropriately and LPN assisted patient with air for approximately 2 minutes. EMS contacted. Vitals assessed by RN. BP 90/55, HR 60 and normal, Resp 22. After ambu bag assistance patient reports that she is feeling much better and does not feel short of breath anymore. Lips are pink and patients respirations 18. EMS arrived and assessed patient at this time. Patient reports feeling fine and no other side effects. Vitals taken again by paramedic. BP 124/86, HR 73 and normal and O2 sat 98%. Patient was asked to wait at site for an additional 30 minutes for monitoring with RN. Patient asked how she was feeling multiple times and she states she was fine now. Patient left site approximately 11 a.m. RN contacted patient at home on the same day at 1446 and patient states she was fine and no other reactions. No medications given at incident. Called patient on 03/01/2021 to check in with her. She states "she is doing fine and has had no other issues."

I do not have a peanut allergy but I did eat waffles topped with peanut butter for breakfast that morning. About 30 minuets after eating the waffles I started to feel sick to my stomach, both like nausea and also having to have a bowel movement. I went to lie down in bed and after about 15 minuets my heart began to race and I felt very hot. I got up to get my pulse oximeter and noticed my face was very red and I had red blotches down my neck, chest and shoulders. My pulse was at 120 so I laid back down for a few minuets. I felt like I needed to have a BM so got back up to go to the toilet when I saw the hives were now down my arms to my wrists so I took 1 Benadryl 25 mg. I still did not have a BM or vomit. My chest began to have tightness and pressure and I felt short of breath. I was home alone and was feeling very scared. I took 2 aspirin 325 mg each. I unlocked the front door and got my daughter's Epi-Pen Jr. 0.15 mg. I waited a few minuets yet and began to sweat heavily, I was feeling cold and like I was going to faint. I gave myself the Epi-Pen Jr and called 911 around 11:50 AM. I never lost consciousness thankfully. EMS arrived and gave me another 25 mg of Benadryl IM in my left arm and they started me on fluids. I received a prednisone and pepcid shots at the hospital.

After 15 minutes of my first vaccine, I experienced hives in my right arm and left arm. The hives also radiated to my back, face and chest. I felt my chest and throat closing up on me. Every once in awhile I get an itchy spot where the first dose vaccine was injected. I did not get my 2nd dose vaccine due to my first dose symptoms.

Severe nausea. Fainting, loss of consciousness for several minutes, unresponsive, required 911 call. Severe calf muscle cramp of right leg.

Approximately two minutes after I received the vaccine I had a strange feeling in my right arm (where I received the injection) that went away after about 30 seconds. About two minutes after that, I developed a bitter taste on my tongue that later spread to the rest of my mouth. Several minutes later, my lips began to tingle and swell, then my mouth (i.e. my soft palette) began to swell as well. About forty minutes after I received the vaccine, I began developing shortness of breath and spiked a fever. The on-site doctor administered an Epipen and I was transported to the ER. While at the hospital I had a blood drawn, a COVID test, a chest X-ray, and multiple EKGs performed. I was discharged about 2.5 hours later.

I?ve had a severe fever, headache, chills, and heart palpitations. I was surprised that I was getting heart palpitations. The symptoms were starting to reside.

About 45 minutes after receiving my vaccine I started feeling a tightness in my throat. I then became lightheaded and shakey. I was driving so I pulled over and called 911 who transported me to Hospital. The tightness and pressure moved down to my upper chest area also and my hands were tingling. I was given benadryl, pepcid and prednisone at the ER. About 30 minutes later I was feeling much better except for a scratchy throat. I was sent home where I slept the majority of the rest of the day. The next day I woke up with a very sore arm, very tired and a headache. Today the injection site is still a little sore and I have a headache.

High blood pressure; Bad headache; Hallucinations; Temperature went to 104.6F; A spontaneous report (), was received from a consumer (patient), a 41 years-old female patient, unknown race and ethnicity, who was administered Moderna's COVID-19 vaccine (mRNA-1273), and experienced hallucinations, high blood pressure (hypertension), temperature went to 104.6 F (pyrexia), and bad headache (headache). The patient's medical history included COVID-19 diagnosed in Oct 2020. Concomitant medication was not provided. On 05 Feb 2021, approximately one day prior to the onset of events, the patient received their first of two planned doses of mRNA-1273 (batch number: 030M20A) intramuscularly for the prophylaxis of COVID-19 infection. On 06 Feb 2021, post vaccination, the patient's body temperature was 104.6 F, and hallucinations. On 09 Feb 2021, the patient woke up with high blood pressure and had a bad headache. Subsequently, the patient went to emergency room on the same day. Treatment medications included acetaminophen and ibuprofen. Action taken with the second dose of mRNA-1273 in response to the events was not reported. The outcome for the events, hallucinations, high blood pressure, temperature went to 104.6 F, and bad headache were considered as unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.

I had heart palpitations while taking a hot shower around 7 pm the day following my shot. The palpitations lasted for about 20-25 minutes and while I was having the palpitations, my fever was 103.

Within 1-2 minutes of taking the vaccine , I started having shortness of breath, my heart rate was rapid, severe chest tightness, and dizziness , tingling in the whole body , face became pale and flushed .

With the second dose I had bad headaches, fever (99.9F), injection site got swollen after a couple of days, painful, had to use ice pack and it still hurts (not swollen anymore) ? symptoms were milder than 1st dose, heavy bleeding for an extended amount of time even with meds to try to stop it and the coloring was darker, brown, not really bright red as usual. I still have a little bit of headache not as bad as in the beginning and body aches and pains.

Had COVID shot March 2, got headache right away, lasted 4 days, resolved. Then on March 8 she had a stroke affecting R side of the body. It was not severe, and it is already partially recovering.

Chief complaint of tightness in chest lasting for approximately 8 minutes. No SOB noted. BP 141/68, P 74, R 16. Patient remain under observation for 30 minutes. Released at 11:45AM, patient denies any chest tightness, pain or distress. She stated that after Dose #1 she experienced similar symptoms as well as lymph nodes swelling.

I?ve experienced severe allergic reactions to many things. I?m now allergic to soy, yeast, wheat, coffee, casein (dairy) peanuts, green beans/ legumes, eggs, onion and celery. I?ve had a huge rash that broke out on my left arm that started at the spot where I received the injection. Now I?ve been experiencing my mouth and tongue swelling to the point that my throat has closed up. I?ve been hospitalized as air wasn?t going through my body. I had to inject an Epi-pen in my leg, and be taken to the hospital. I?m currently on high dosage prednisone, Benadryl and several other meds to address the swelling in my tongue that happens daily. I am desperate to find out if there is anyway to stabilize anything that vaccine had in it to see if this condition will get better.

1. 3/13 @230pm fever 101.6, took Tylenol and temperature went to 99.7 by 430pm. Have been cold (chills) since having the vaccine on Friday, though not feverish throughout. 2. 3/14 @ 0830am red and raised rash from above shoulder mid upper arm, raised higher at injection site 3. 3/14 @ 0515pm lower lip (left side) swollen, red and numb. Sore inside roof of mouth (left upper). Tongue slightly swollen, but not hindering breathing.

Onset of leg weakness and instability that has progressively worsened. Constant imbalance noted more in standing and with walking resulting in feeling like I am "rocking on a boat" constantly. Increased sway in static standing that is more pronounced with rotational movements, eyes closed, and decreased base of support. Ataxic movements and lateral veering with walking at times. Episodes of low blood pressure/significant decrease in blood pressure from sitting to standing, tachycardia, and resting tremors in the hands that are intermittent in nature. Feeling of head being "in the clouds" constantly where something is not right.

Got the shot Friday March 5th. Sore arm and muscle aches like the first dose on 2/5. Woke up March 7th with swollen lips/throat/tongue. went to urgent care and received an EpiPen and steroid. Monitored for a couple of hrs and went home for a nap. (refused the ER at this time as I felt better). Woke up around 2:30 and my symptoms worsened . We to ER and received another Epipen for anaphylactic shock. Remained at the hospital for 5 days. Had 5 episodes while there. Also, had tightening in chest and what felt like a heart attack. Been resting, still very tired and swollen nodes in my neck and sore throat as well as aches. Also, might be developing thrush. Didn't run a fever and Ive never had an allergic reaction before this.

"Moderna COVID-19 Vaccine EUA" - at minute 14 after the vaccine I got really light headed and funny feeling, my heart was racing but I was not having any trouble breathing. The nurses at the site monitored me until my vital signs returned to normal. I was very tired for a few days after and had a headache. Sevens days later, 03.15.2021, I woke up to my arm being tender again and noticed a big red spot/rash right by the injection site of the vaccine.

Patient has history of heart problems (unspecified arrhythmia), type 2 diabetes, food related allergies and previous meth use. She denies any recent meth use or previous anaphylactic reactions. She received her vaccine dose at approximately 1331 and started complaining of shortness of breath and palpitations approximately 5 minutes after. She denies any chest pain, throat tightness, itchiness or swelling. She appeared lethargic, awake and oriented x 4, speaking in full sentences, diminished breath sounds bilaterally, no respiratory distress, Her vitals were stable (BP 126/84, HR 73, RR 24, SaO2 94% RA). She self administered ProAir MDI 2 puffs. Her breath sounds improved and palpitations resolved. Her reaction time lasted until approximately 1351. She was educated on sign and symptoms of anaphylactic reactions and strict ER precautions.

PT BECAME HYPOTENSIVE, DIZZY. BP: 90/62, HR WEAK 58-60. HYDRATED WITH WATER 16 OZ, LYING SUPINE. AFTER 10 MINUES, BP 110/60. COLOR RETURNED. DIZZINESS GONE. SENT HOME

Anaphylaxis. Initially, pt experienced palpitations and tightness in throat after vaccination and wasn't sure if she was experiencing swelling in her arms. BP was 130/79 and HR 93 initially. Pt started to feel better without intervention but given diphenhydramine as a precaution while we continued to monitor her. 10 mins later she started to have tingling in lips and tongue and visible lip swelling in addition to palpitations. Immediately administered Epipen (0.3mg) x 1. EMS was called. No worsening but not improvement after 5 mins so a second dose of Epipen (0.3mg) was administered. By the time EMS arrived (9 mins after first epipen dose) pt was feeling better, swelling had resolved, no throat tightness. Pt was transported to local hospital by EMS for monitoring.

1:30pm Post vaccination reports "feels like heart pounding" w/no additional associated symptoms; medical monitoring x 30 min. vitals assessed: BP158/88 P74 RR 16, continue rest and monitoring; 1:56 pm BP 126/81 P68 "feels better". Released from facility w/self.

Numbness in lips and tongue, tingling and numbness in right arm and 3rd and 4th fingers on both hands, raised blood pressure, broke out in hives all over body. Two weeks later and still no feeling in tips of fingers

CONGESTION, EAR FULLNESS, SINUS PRESSURE, NOSE BLEEDS- NOTED ON 03/05/2021 PATIENT ACCEPTED ADMINISTRATION OF ANTIBODY INFUSION.

Sharp headache - same day Muscular Pain around injection site - same day (lasted until 3/18/21) Joint pain - same day (lasted until 3/18/21) Nosebleed - 3/18/21 (8:13p - 8:37p) Mild cold symptoms (3/17/21 onward)

After approximately 5 minutes after receiving Dose 1 of Moderna Vaccine patient complained of metallic taste in mouth, dizziness, and increased heart rate. Patient sat down in chair. Pharmacist called 9-1-1. Patient complained of swelling of throat. Paramedics evaluated patient for hives, took vitals, and evaluated patient. Patient was ok, but still complained of swelling in her throat. Paramedics told patient to take Benadryl to decrease swelling. Patient refused to go to hospital.

About 12 hours after my first vaccine I developed chills, sore arm and gradually a low grade temp. I also began to noticed an elevated heart rate. This went on for about another 12 hours. Early in the morning on Sunday 1/17, I woke up sweating and still high increased heart rate. I went to the ER and was treated like an adverse reaction to the vaccine. I was not able to work both Saturday the 16th or Sunday the 17th.

During patient observation time, pt. stated she could not wait any longer to use restroom, urge became strong. When exiting restroom pt. was flushed (red) in face and hands, became weak, tachycardic, and blood pressure became elevated. Pt. was still able to communicate verbally. Also, experienced chills. EMS called and transported pt. out.

several hours, 8, after getting the COVIDvaccine, my throat began to feel tight and my chest began to feel tight as well. I began to wheeze and notice that my breathing had changed and it was not normal. symptoms similar to anaphylaxis of when I was given Rocephin in my teen years and had anaphylaxis within a minute of receiving that medication.

TIGHTNESS IN CHEST (BRIEFLY RIGHT AFTER INJECTION), FATIGUE, SEVERE JOINT PAIN STARTING NEXT MORNING FOR 12-16 HOURS DEVELOPED FEVER BLISTER-WITHIN 12 HOURS OF INJECTION

Sore arm all day. Woke up at 1am extremely nauseated, headache, and in sweats. Went to kitchen to get some nausea meds and felt my ears closing. I couldn?t breathe and apparently passed out. My husband called 911 and I came in and out for about 30 min he said. I couldn?t open my eyes and couldn?t feel my legs. Bp was normal and so was blood glucose. They gave me some fluids and nausea meds and I started coming too. Today I am extremely achy and terrible headache, scared to get out of bed.

10 minutes after injection, patient with feeling of heart racing. No other symptoms at all including SOB, wheezing, vomiting, diarrhea, rash, abdominal pain. Vitals: HR 82, Sat 99%, BP 123/68. Patient given ice pack and observed for 30 minutes with no other symptoms. Released home without issue. Instructed to F/u with PCM.

March 5th left side of face started twitching lasted all weekend. Headaches, arm pains, chest pains, tingling of toes and hands, numbness of tip of tongue started March 8th, 2021. Currently 3/21/2021 my face is tingling continuously with small twitches from time to time. Headaches off and on lasting about 4 hours. My right eye hurts, feels like electrical shocks to my head and scalp of my head periodically.

I received my vaccine on Friday, within the first 10 minutes, light headedness, dizziness and headaches. Paramedic took my blood pressure, I had an elevated BP. I do not have a history of hypertension. Within the hour, I started to have body aches and chills. Early the next morning (2 am) Saturday, the body aches were so bad that I could not get out of bed. My whole body felt as if I had bloodclots all over, it ached all over and felt very heavy. I started having night sweats, chills and my head was aching badly. I had to call off from work. I took Benadryl and drank lots of water and warm tea. This feeling lasted all day. I stayed in bed wrapped up the covers. Sunday morning I woke up (6 am ) and was my normal self.

Vaccine dose 1 rash and itchy for 3 weeks and slight shortness of breath and tightness Dose 2 severe rash on neck and chest with mild shortness of breath and tightening in chest lasting 24 hours.

Immediately after getting the shot in my left arm, it felt like something shot up my neck and down my arm. And the site was sore. Driving home about 25 ish after My chest felt tight and my entire left side was sore The bottom of my left foot felt like it was on fire By the time I was home, my entire body is sore With in an hour, every fibromyalgia trigger point lit up like a Christmas tree. And headache (not migraine) My left arm feels like it weighs 40lbs (I?m 107lbs) The benedryl has worn off and my arm keeps feeling like it?s burning My calves are beyond killing me and random parts of my left side of my body feel like they are burning and the right side is starting as I?m typing this This doesn?t feel like my typical day of fun with my usual daily symptoms I have had allergic reactions to everything I highly suspect I have a very high sensitivity to endocrine disrupters Don?t know if this is how my body is responding to the vaccines with all my autoimmune issues that have not officially been diagnosed /just suspected Or if it?s an allergic reaction In October of 2020 I had an interlaminar epidural steroid injection, immediately after I couldn?t move and my chest also tightened up. The injection site hurt to the touch for a week and got a nasty rash around it I took adderall, Allegra, benedryl allergy+ congestion and vitamin d prior to vax After about an 1.5 hours after the vax methocarbamol, Percocet and vitamin b12 and had a liquid iv beverage

Felt fine yesterday. No pain in my arm. Sudden flare of post shingles nerve pain, have had it before. Feels like bugs are crawling on my leg. Random racing heart beats, sweating, mouth sores, have been giving wrong phone numbers and addresses, really foggy

Patient has a history involving fear of neeedles and experienced a near syncopal episoide. Patient laid down and felt better. Refused transport to the hospital.

After 10 minutes from the Moderna Vaccine, experience Tachycardia of the Heart, heart rate reach 160. Increase of blood pressure, numbness is lips, and numbness of the right cheek. Was rushed by Ambulance from Vaccination site to Hospital

Pt reported a bad taste in her mouth after receiving the 1st dose of COVID vaccine. She drank water and sx improved, but then returned. She then reported chest pressure, left side. She refused further eval in the local ED.

Within 15 minutes: Dizziness, light headed, seeing stars, blurred vision, racing heart rate. I thought at the time I was having a panic attack. I tried to slow my breathing and relax. It did not help any. I monitored my Heart rate on my watch. My EKG said my heart rate was high and marked 138 at one point while at rest when my average resting rate is 52. By the time I walked to my car I felt chest pain and pain in my neck. It was a tightening and burning. In my car, at 1:25 I took antihistamine in a 24 hr dose of Claritin and an inhalation of OTC Flonase. I felt my body calming slightly, but not 100% returning to normal. I alerted my Dr. and she agreed I should not have the second dose without first taking an otc antihistamine and also having an epi pen on hand. I stayed with a friend so I was not alone, and continued to rest. At 6:12 i tried to move around and my hear rate shot back up to 132. I sat back down. At 9:30 I still have pain like I?ve been punched really hard in the chest.

Patient described burning and itching of the esophagus as well as chest pain. She was given 20 mL of bendaryl and watched for over an hour. I followed up with the patient at 6pm (6 hours post vaccination) and she still reported chest pain. I advised that she go to the ER.

Swollen itchy rash around injection site 13 days after vaccine. Also, extremely low body temp (under 93°). Nausea, headache, kidney pain, felt loopy. All occurred at time the rash was discovered.

Initial side effects included fatigue, intermittent chills and fever (unmeasured), severe body aches, and injection site pain and soreness. On day 4, the chills and injection site complaints were gone. On the night of day 4, I developed a dry cough and throat irritation. On day 5, my body aches were gone, but I had a low-grade fever all day and developed hives-like spots throughout my body, although they were mild and did not itch. I lost my appetite. Fatigue lessoned to tiredness, but the dry cough and throat irritation worsened. On day 6, my body temperature normalized, at least for the most part. My cough and throat irritation continued to worsen, and I received a positive COVID-19 antigen test result. (My PCR test result was negative.) On the night of day 6, I developed chest discomfort. On day 7, my symptoms continued, and I also had taste disturbances with certain foods. On day 9, my appetite improved a little bit, but additional hives-like spots developed. On day 9, I also re-tested for COVID-19. Both my antigen and PCR results were negative. On day 10, my dry cough, throat irritation, and chest discomfort began to fractionally improve, but I suffered some mild body aches again. Today, on day 12, I am still suffering from a dry cough, throat irritation, and chest discomfort, with decreased appetite.

1:35pm Post vaccination reports feeling dizzy w/palpitations; medical monitoring w/vitals assessed: BP 123/85 P71 RR 19 O2 sat 99% RA; rest/ po hydration offered; 1:45pm reports symptoms resolve w/no additional complaints; released from facility w/self.

Site: Pain at Injection Site-Mild, Systemic: Confusion-Mild, Systemic: Dizziness / Lightheadness-Mild, Systemic: Fainting / Unresponsive-Mild, Systemic: Seizure-Mild

Patient was observed post Covid-19 immunization for 30 minutes based on pre-vaccination screening . During the observation period, she experienced an adverse reaction with the following symptoms: hives, mouth dry, lightheaded, throat itching, chest tightness. Assessment : Time of assessment 1035. Actions taken: Patient was placed in a wheelchair, taken to the triage area. She had hives to her arms, behind her neck and ears. She was flushed in the face. BP 138/91, P 135 initially, last BP 132/91, P 116. Medications administered: 1039 Benadryl 50 mg IM to RD given; 1047-Solumedrol 125 mg IV given via 20 G Saline Lock Left AC all by EMS. Disposition: Hospital via Ambulance Patient's symptoms of rash improved, she still had itching of her throat and chest tightness with no audible wheezing after medications given and when ambulance arrived.

About 30 min after - felty very drowsy About six hours later - Chills fatigue fever body aches About four hour later - heart palpitations and facial numbness About ten hours later - abdominal pain

Pt stated that she had severe swelling and pain at axillary lumph node, as well as tightness/pain across chest

Never seen anyone bleed this much; Numbness in her fingertips and toes; Tingling in finguretips and toes; Throat closed up; Eyes swollen; Swollen itchy hives; Felt a little dizzy; Discoloration in her skin pattern; Full body rash head to toes; Rash; Swollen itchy hives; Ungodly itch open sores; Hives so large and severe; Low grade fever; Headache; Vomiting; Diarrhea; They were able to stop her from going into anaphylactic shock; A spontaneous report was received from a consumer concerning 41-year old, female patient who received Moderna's covid-19 vaccine (mRNA-1273) and developed felt a little dizzy, diarrhoea, vomiting, headache, low grade fever, full body rash head to toes, hives so large and severe, throat closed up, eyes swollen, discoloration in her skin pattern, numbness in her fingertips and toes, tingling in fingertips and toes, swollen itchy hives, ungodly itch open sores, rash and never seen anyone bleed this much, they were able to stop her going into anaphylactic shock The patient's medical history was not provided. Products known to have been used by the patient, within two weeks prior to the event, included tumeric, multivitamin, vitamin d, lexapro and adderall. On 22 Jan 2021, approximately 1 day prior to the onset of the symptoms, the patient received their first of two planned doses of mrna-1273 (batch number: 039k20a) intramuscularly in the left deltoid for prophylaxis of covid-19 infection. On 23 Jan 2021 the patient had experienced felt a little dizzy, diarrhoea, vomiting, headache, low grade fever, full body rash head to toes, hives so large and severe, throat closed up, eyes swollen, discoloration in her skin pattern, numbness in her fingertips and toes, tingling in fingertips and toes, swollen itchy hives, swollen itchy hives, ungodly itch open sores, rash and never seen anyone bleed this much and they were able to stop her going into anaphylactic shock. Treatment for the event included was given steroids, benadryl, and prescription antihistamine. Action taken with mrna-1273 in response to the events was not provided. The outcome of the events were not reported.; Reporter's Comments: This case concerns a 41 Y/O F with serious unexpected dizziness, urticaria, diarrhea, vomiting, pharyngitis, eye swelling, skin discoloration, hypoesthesia, paresthesia, pruritus, swelling, rash, hemorrhage, pyrexia, headache. Event onset Day 2 after first dose mRNA-1273. Treatment prevented anaphylactic shock. Event outcomes unknown. Based on current available information and temporal association between use of the product and start date of the event, a causal relationship cannot be excluded.

Had chest pains, heavy arms, and vomited multiple times. Went to ER and showed elevated ST levels on EKG.

This spontaneous case was reported by a consumer and describes the occurrence of CHEST PAIN (Chest Pain), CHEST DISCOMFORT (Chest Tightness), LIP SWELLING (Swollen Lips) and ADVERSE REACTION (allergic reaction to the vaccine) in a 41-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included No adverse event. Concomitant products included LEVOTHYROXINE SODIUM (SYNTHROID) for an unknown indication. On 06-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 06-Feb-2021, the patient experienced PAIN (Body Aches) and PYREXIA (fever). On 06-Mar-2021, the patient experienced CHILLS (Chills). On 15-Mar-2021, the patient experienced PRURITUS (Itchiness), ERYTHEMA (Redness) and URTICARIA (Hives). On 20-Mar-2021, the patient experienced CHEST PAIN (Chest Pain) (seriousness criterion hospitalization), CHEST DISCOMFORT (Chest Tightness) (seriousness criterion hospitalization) and LIP SWELLING (Swollen Lips) (seriousness criterion hospitalization). On an unknown date, the patient experienced ADVERSE REACTION (allergic reaction to the vaccine) (seriousness criterion hospitalization). The patient was hospitalized on 20-Mar-2021 due to ADVERSE REACTION, CHEST DISCOMFORT, CHEST PAIN and LIP SWELLING. At the time of the report, CHEST PAIN (Chest Pain), CHEST DISCOMFORT (Chest Tightness), LIP SWELLING (Swollen Lips), PAIN (Body Aches), PRURITUS (Itchiness), ERYTHEMA (Redness), URTICARIA (Hives), ADVERSE REACTION (allergic reaction to the vaccine), PYREXIA (fever) and CHILLS (Chills) outcome was unknown. Following the first dose of the vaccine, the patient experienced fever, chills and body aches that lasted for 24-36 hours and then subsided. Following the second dose of the vaccine, the patient initially experienced the similar side effects of fever, chills and body aches that lasted for a similar time frame. Then, on 15 Mar 2021, the patient began to have full body itchiness. No rash was present, but wherever she would itch would turn red and break out into hives. This continued and then on 20 Mar 2021, the patient was taken to the Emergency Room because she experienced tightness in her chest, chest pains and swelling in her lips. There she was treated for an allergic reaction to the vaccine. Some symptoms have improved but all are still present at the time of the report. Treatment details included Pepcid, Claritin D, Mailax, Prednisone, and Benadryl.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.

I developed a sudden, sharp stabbing pain in the left side of my head while at work. I had not fallen nor had any injuries/illness. I went to ER; CT scan was concerning for clot in sinus so I was sent via ambulance to inpatient neurology where further MRI/MRV scans determined it was not in fact a clot, but a small bleed of unknown origin. Again, I had no injuries. I was hospitalized while multiple scans were completed along with lab work. Home now following up with neurology, still have head pain, unable to fully work, etc. Hematoma is still there but not growing.

I immediately got a headache after the shot and became dizzy several hours later. I went to bed around 9 pm and then woke up around 10 am and was very dizzy and my arm was in severe pain. I had to vomit so I got out of bed and fainted and fell to the floor. I got up again and then fainted and hit the floor. My husband then called 911 and I was transported to the hospital.

Patient is a 41 yoF that was transferred to Medical Center on 4/10/21 after being seen at a free-standing Emergency Department for chest tightness and shortness of breath worsening over the past week. Pt reportedly received both COVID-19 Moderna vaccines (1/24/21 and 2/26/21). Over two weeks prior to admission she was exposed to her brother who was found to be COVID19 positive. The patient stated that her symptoms started 3/30/21 and she was found to be both COVID19 and influenza positive on 4/2/21 prior to admission. She did not take COVID precautions when she was exposed to her brother. Her symptoms started with fever, chills, myalgias, fatigue, nausea, vomiting, and loss of taste/smell. She also reported her pulse ox revealed O2 sats at 88%. She was admitted to the hospital 4/10/21 and later discharged on 4/15/21. She was given supplemental oxygen, Remdesivir, Dexamethasone, and convalescent plasma while being admitted.

Day 9 after injection noticed small suspicious bruises. Day 10 slight vaginal bleeding assumed was UTI called for prescription was given Bactrim. Day 12 large contusion on back, right breast, left hand and left foot. Went to emergency per doctors request. Diagnosed with ITP and confirmed UTIPlatelet level was severely low (18,000) . Changed antibiotic from Bactrim to Kefflex and was given 60mg of Prednisone. Increased platelets to 68000. Reduced Steroid to 20mg. due to progress. Continued to increase platelets. Stopped steroid and continued to see increase in platelet production. Today levels are 148,000. Did not take second scheduled vaccine.

In the middle of the night I passed out while walking from the bathroom. I broke my front tooth in half and smashed in 2 other front teeth. Also bruised cheek, lip, and knee. I had been feeling chills, aches, and flu-like symptoms throughout the night. It required a dental surgeon, dentist, and probably braces. The advice nurse advised going to the Emergency Room due to her concern about a head injury.

Fever, body aches, chills, headache, elevated heart rate, elevated blood pressure, itching and rash at injection site

I had chills, headache, and was nauseous all day but around 630 I passed out and smacked my face when getting out of the shower.

30 minutes after vaccination: numbed left side of face Around 4 pm started with ringing ears, lightheaded . Light chest pain but not too bad to go to the ER.

45 minutes following the injection, diziness and near fainting.Within a few hours, severe arm pain, limiting range of motion to about 30%. The day after the injection experienced diarrhea all day, as well as ongoing severe arm pain, limited range of motion to aprox 30%.

Nausea, arm numbness, weakness elevated blood pressure, (210/80) heart rate of 120bpm. All occurred 5 min post vaccination

Patient took ibuprofen, 2 zyrtec, 2 pepcid and ubrelvy that morningat 7am. Injection was administered at 9:30am, reaction started at 09:45am increased phelgm, severe migraine, tightness in chest, tongue swelling face swelling, patient took 4 zyrtec, 4 pepcid, ubrelvy. By 4pm tightness of chest and increased mucus subsides. That evening patient took 2 zyrtec 2 pepcid, 2 benadryl that evening, continued to have severe migraines, face and tongue swelling until 1/5/2021.

Patient had sharp pains in arm after COVID-19 vaccine near injection site. Observed patient for 30 minutes and gave a cold compress. Patient returned to work and later reported palpitations and "heart racing." Checked vitals BP 130/80 and HR in the 80's. HR later jumped to 100's.

Presented with pain at injection site for days1-4 followed by flat, blanchable welt on left deltoid that was warm to touch and erythemic, approximately 1.5?x2.5? in size, on day 10. Afrebile.

NauseaVomiting, HYPERtension, Tachycardia, throat swelling Narrative: Went home after vaccine and starting vomiting, throat swelling. HR and BP elevated Went to ER was given beta blockers, in hospital for observation.

Pt received vaccine and ten minutes later began complaining of numbness to her face and heart palpitations. At the this time she denied dyspnea, difficulty swallowing, chest pain, nausea/vomiting. She also experienced facial flushing, nausea/vomiting, and diarrhea. She was given 50mg of diphenhydramine intramuscularly. She seemed to make a full recovery.

Headache, HYPERtension, neck stiffness, left arm weakness, Narrative: individual states having these symptoms all the time, almost resolved when left with husband driving home

Approximately 30 minutes post vaccination, patient became c/o of palpitations and confusion with syncope and loss of consciousness. Later the patient developed hives.

Dizziness, Headache, Myalgia, Tachypnea, CoughWheeze, NauseaVomiting, Palpitations & Tachycardia & Narrative: Patient stated that after receiving injection on 01/06/2021, tasted metal in her mouth. No reaction noted in clinic after vaccine administered. Patient states that after returning home, she began to have chills, headache, and muscle aches. Could not sleep. On 01/07/2021. Patient continued to experience above symptoms. Approx. 13:50 on 01/07/2021. Patient presented with respiratory difficult, tachypnea stridor, and stated she felt as if her airway was closing. Patient was vomiting and was tachycardic. Epi-pen administered via left lateral thigh. Patient administered 50mg of PO Benadryl, and 2 puffs of albuterol inhaler. Continuous V/S initiated. Patient began to experience relief of symptoms. HR and blood pressure remained elevated, but this was expected side effect of epi. SpO2 stabilized around 99% on room air. Patient was monitored for 60 minutes. Transportation home was arranged and family was present to observe overnight.

Ten minutes after vaccine administration patient started complaining of n/v, palpitations, lightheaded and was observed with cold clammy skin and tachycardia. Upon observation 911 was called.

Post vaccine next day i had scapula pain and chest burning, as the days went the chest burning became more intense. Thought maybe covid, took test and it was negative, so now 7 days post vaccine still chest burning and scapula pain is intermittent. Contact pcp, going for bloodwork and chest xray. Outcomes to be determined. Pcp believes this is a vaccine reaction.

Patient reported itchy dry cough, slight tightness in back of throat & feeling her HR was high. Vitals taken by nursing staff x 3, 13:00-13:20 (140/89, 114/77, 120/81) 25mg of PO diphenhydramine administered 40minutes of observation complete

Thursday night shortly after the vaccine I was exhausted and headed home to go lay down. While driving, I developed a severe headache. I went home and went to sleep really early. Friday morning, woke up, went to work. Extreme lethargy and severe headache. Left work early (2 ish) with joint pain, headache, lethargy. In the evening (still Friday) I went to the grocery store and walking in the parking lot to the store my joints hurt with every step. I sent my partner in and I went back to the car. I could not do it. Went to sleep soon thereafter. Saturday morning, we woke up and had planned to go to the cabin. We were trying to run errands (coffee shop, post office, bank...simple errands) and I was exhausted and feeling bad. Still headache, lethargy, achy. Assumed it was flu like which was a side effect, so I continued to press on through the discomfort. Left for the mountains. less than 1 mile from home, started to feel tingling and "buzzing" throughout my body, like a vibration sort of. Stayed quiet and thought about this. Another block or two and the feeling was in my tongue. Then I felt it in each tooth root and spoke up. I asked to go home and rest for 30 minutes before going to the cabin. At this point, I could not move my hands. We got to the house and I could not open my car door or take off my seatbelt. I had hand paralysis for about 10 minutes. Made it in the house. Got to the couch and laid down for about 60 seconds. Got up had to use the restroom. Solid, not diarrhea, but took 45 minutes. Apparently, I was pale like a piece of paper. I do not remember being in the bathroom for 45 minutes, I felt like it was 5 minutes, partner said 45 minutes. Made it back to couch, laid down, freezing! Under 2 blankets, one of them was an electric blanket on high. Began throwing up, clear bile. Had not eaten anything yet. Stayed on couch, also lost track of time, was there for 5 ish hours. Tried to eat something so I could take Tylenol for the headache. Barely ate anything, so I never took the Tylenol. It lessened. Cabin trip cancelled. Still lethargy and dizzy yesterday but no joint pain, no nausea. Now, Monday morning, still dizzy/lightheaded. Symptoms are subsiding, but not gone.

The patient observed to be flushed, lightheaded, and nauseous 10 min after the vaccine. Denies, trouble breathing, chest discomfort, or difficulty swallowing, facial swelling, or notable rash. Did not eat breakfast that morning and was nervous about receiving the vaccine. Slightly tachycardic. Given cetirizine 10 mg with relief.

ON 12/24/20 AT 7PM, DEVELOPED RIGHT SIDED CHEST/ARMPIT/UPPER ARM PAIN. LASTED 7 DAYS PRIOR TO RESOLVING. WAS SEEN IN THE EMERGENCY ROOM.

Patient reported "burning in chest", dizziness, and nausea within one minute of receiving vaccine. Patient reports these symptoms were consistent with her history of anxiety. Denies SOB, swelling, rash, throat closing, tingling around mouth or throat, stridor, Monitored for 30min. Patient reports symptoms resolve when she thinks about other things. By end of monitoring period, patient was doing well.

chest pain- P 79, BP 131/98, 99% SPO2, Throat itching, Taken to ED Left sided pain Sinus tacky- troponin normal- EKG normal Benadryl 50 mg IV and Zofran administered In ED 3 hours

The following actions were performed: Patient states that she is having pain where the vaccine was given. She reports that there is a warm traveling sensation from the injection sites to her neck and face. She also reports a tingling numbness and pressure sensation in her nose, chin and forehead. She started to complain of a headache at 12:53. Bendaryl 25mg administered as a single dose at 12:35. Patient was brought into the exam room sat down. She was monitored at 5 minute intervals for her BP, HR, and Pulse Ox. Her vitals are stable. She has no complaints of any SOB. She did complain of some chest tightness she said was anxiety and she was not concerned with it. She said it did not feel she like she needs any emergency treatment.

Reported Symptoms: low grade fever, hives ?head to toe? , fatigue, cold sweats and does not feel well at all, feeling tachycardic and palpitations Date of Onset: *most symptoms ongoing from 01/11; 01/12/2021 hives Medication taken for Symptoms: ?steroids and Benadryl?

Warmth fling rush from shoulders up through neck to top of head Muffled hearing Felt faint Blood pressure drop

chest tightness shortness of breath throat closing 30-45 minutes after injection. Left work, drove home and used rescue inhaler and took a prednisone. states she was fine after that.

Chest pressure, anxiety, headache, shortness of breath, dizziness starting 15 minutes after vaccination. Monitored and offered ED but refused.

I felt very heavy (especially my limbs) and had a slight headache on Thursday (the day after receiving the vaccine). This feeling continued into Friday morning when I nearly passed out (blacked out and collapsed for a split second) as I was crouched position for approximately 10 minutes at work. I felt dizzy and slow moving for the next several hours. My blood pressure was rated as normal, blood oxygen normal, and pulse slightly low by a nurse on staff who took my vitals after the episode. My temperature, which had been 97.8 prior to the event that morning (typical for me) was elevated during this time to 100.2 and returned to normal after approximately 4 hours without medication. I was fatigued, so I slept for approximately 4-5 hours that afternoon and began feeling better the following day (Saturday).

Moderna covid-19 vaccine EUA Hour after shot, body broke out in hives with itching and elevated heart rate. Lasted about 15 minutes.

REPORTED THAT DURING THE EVENING OF THE INJECTION SHE EXPERIENCED RAPID HEART RATE AND SHORTNESS OF BREATH. THE NEXT DAY SHE EXPERIENCED RAPID HEART RATE, SWEATS, SHORTNESS OF BREATH, FEVER, PAIN AT INJECTION SITE AND ARM, KNOT UNDER ARM, NUMB FINGERS ON SAME SIDE, AND FATIGUE.

Vaccine given at 8am on 1/5/21. The same afternoon, burning feeling in chest and head, flushed feeling, slight chest tightness and headache started. The symptoms have been returning daily since then. No fever, blood pressure, SpO2 and heart rate in the normal range.

17 minutes after injection, . Moved to a clinical room. BP initially elevated and tachycardic. Respiratory rate and pulse ox normal. Patient given oral Benadryl, IM epi and IV Solu-medrol. HR slowed and patient became hypotensive. IV fluids initiated. Patient observed for a couple of hours and discharged home. Patient called her allergist who initiated steroids and continuous histamine blockers.

3.5-4 hours after injection I experienced increased heart rate. My normal resting is around 100bpm. My BP was rather normal but my heart rate was up to 125bpm. I am uncertain when my heart rate regulated but do know I slept regularly that night. I also have severe anxiety so I was hesitant to report this issue due to being unable to distinguish between the two. Day after injection was sore arm, mild fatigue and headache for most of the day

Pt had pain/redness/swelling within 4 hrs after receiving injection in L upper arm. +12 hrs later, L upper arm became extremely itchy/hot to touch and developed a half dollar size bright red circle at injection site. After 24hrs, symptoms subsided. 7 days after receiving initial injection, pt was weight lifting and upper L arm became itchy and started to develop a welt approximately the size of a half dollar that was blanched in color and hot to touch. Discomfort subsided approximately 24 hrs later and pt now reports discoloration and some irritation at injection site.

APPROXIMATELY 8 MINUTES AFTER RECEIVING MODERNA #2 VACCINATION, CLIENT DEVELOPED DIZZINESS, SHORTNESS OF AIR, PERIPHERAL TREMORS/NUMBNESS. CLIENT BECAME PALE AND DIAPHORETIC. CLIENT STILL ALERT AND ORIENTED X3. BENADRYL 25 MG ORAL GIVEN FOLLOWED IMMEDIATELY WITH EPI PEN ADULT DOSE @ 10:56 AM. VITAL SIGNS @ 10:54 WITH BP: 146/72, P: 131, REPIRATIONS 30, SKIN PALE/DIPHORETIC PRIOR TO ADMINISTRATION OF EPI. 2ND SET VITAL SIGNS @ 11:00 150/74, P: 119, R: 30 SKIN PINKINING/IMPROVING DIAPHORESIS STILL REPORTS PERIHERAL NUMBNESS/VISUAL PERIPHERAL TREMORS STILL PRESENT/REDUCED. 3RD SET VITAL @ 11:13 AM BP:136/68, P: 100, R: 26 REPORTS HER TONGUE FEELS THICK. TRANSFERRED TO ER FOR CONTINUATION OF CARE @ 11:20 AM VIA WHEEL CHAIR.

reportedly became ill after she received her COVID-19 vaccine 4 days ago. She developed myalgia and other flu-like symptoms and was followed by SOB in the last 24 hours. She also developed some headache and palpitations with heart rate in the 130s so she went to our ER yesterday and was sent home after she was stabilized. Patient however continued feeling poorly and claims pleurisy and pleurisy further worsened associated with dry cough hence the decision to come back to our ER where she presented febrile, tachypneic and tachycardic. Workups done showed mild hypokalemia, hypoalbuminemia and hypocalcemia. respiratory symptoms found to be related to lung nodule. Pt. also noted to have redness, erythema and itching on Right arm, site of vaccination.

Reported immediate headache, face flushing, nausea-reported no symptoms to staff-returned to work-felt bad and went home. Reported throat swelling and went to ER. Later symptoms worsened and returned to ER-decreased blood pressure, chilling, fever, rattling in chest. Saw MD yesterday and is being treated for bronchitis resulting from COVID-19 vaccine. Has been advised not to complete series.

Patient began to have itching on her legs, which spread to the rest of her body as a macular red rash, she received Epi 0.3mg, Prednisolone 45mg po, Benadryl 50mg po, Famotidine 40mg po. Patient was monitored with BP, HR, RR, pulse ox, all normal with increased BP and HR after Epi administered. She was placed supine with legs elevated above the height of the hear. Pt was anxious so oxygen was administered by nasal cannula at 4 liters per minute. Within the 15 minutes after meds were given, pt had periorbital edema, a "strange " taste in her mouth as well pressure in her chest and the rash did not abate but progressed to her face. EMS came and took pt to ED by ambulance.

Vaccine 1/4 Left arm, ED visit 1/5 due to dizziness, light headed, chills, HA, fever went up to 102.0, almost passed out; oxygen given, HR rate went up to 230, started to have convulsions, o2 sats down, RR 70, given ativan for convulsions; Follow up with Care Spot 1/; MMI 1/13

10 mins after receiving the vaccine, my right hand started to swell a bit and had pain in the wrist and I got the injection in my left arm. Them I went to urinate and it was painful that continued until this morning. My body became itchy all over my blood pressure was 184/107. I was having heart palpitations. I got queasy and didn't feel well. I was given benadryl and zolfran. My blood pressure went down to 151/92 after a bit then after an hour I was still itchy, blood pressure was 133/ 84 but then my throat left side tried to hurt and I Felt like something was stuck in my throat. I waited another 30 thirty mins and left. My left side of throat hurts a little and my left hand still hurts and a little itchy

Patient experienced palpitations and dizziness, and chest pains. Client was cleared with EMS and advised to go to Emergency Room. Patient had driver to drive them to emergency room.

Started 4 days post vaccine (1/11/21) and lasted 10 -12 days. Tightness in chest and neck. Fullness in chest that radiated up to neck w/ warm feeling. Feeling of faintness. Headache. Rapid heart rate while sitting or standing., bending over. Left eye blind spot; 20 minutes on 1/16/21. Anxiety. Advil, Dayquil did not change any of the symptoms. Some residual anxiety issues regarding tightness and rapid heart rate.

1620: After receiving COVID vaccine, pt c/o tingling on lips and face; hx same s/s w/food allergies inc rash/hives 1624: Benadryl 25 mg po given 1628: BP 168/98 HR 88 RR 24 SpO2 100% 1634: States tingling improved but left cheek feels "numb" 1635: DS 109 1638: States numbness feel improved 1647: BP 162/90 HR 88 1652: Discussed elevated BP; suggested f/u w/PCP. Pt driven home by husband.

Extremely fatigued; Tightness in sternum; Bilateral leg weakness; Difficulty in walking; Atelectasis; Anaphylactic shock; A spontaneous report was received from a consumer who was a 42-year-old, female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced anaphylactic shock, extreme fatigue, tightness in sternum, atelectasis, extreme bilateral leg weakness, and difficulty walking. The patient's medical history included allergy to shellfish, bee sting, and mushrooms. No concomitant medications were reported. On 31 Dec 2020, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 intramuscularly for prophylaxis of COVID-19 infection. On 31 Dec 2020, five minutes after receiving the vaccine, the patient experienced anaphylactic shock. Some of the symptoms experienced included chest tightness, difficulty breathing, throat swelling, and weakness. The patient was transported to the hospital by the emergency medical services (EMS). Treatment for the event included epinephrine several times. On 01 Jan 2021, the patient experienced extreme fatigue, tightness in sternum, and weakness at home. She returned to the hospital where she was admitted. It was noted that a computed tomography (CT) scan revealed atelectasis. The patient also experienced extreme bilateral leg weakness and difficulty walking. The patient was advised to be placed in a nursing home/rehabilitation center. Action taken with mRNA-1273 in response to the events was not provided. The outcome for the events, anaphylactic shock, extreme fatigue, tightness in sternum, atelectasis, extreme bilateral leg weakness, and difficulty walking, was unknown.; Reporter's Comments: This case concerns a 42- year old, female patient with medical history of allergy to shellfish, bee sting and mushrooms, who experienced a serious, unexpected event of anaphylactic shock, chest discomfort, muscular weakness, gait disturbance, fatigue, and atelectasis. The event of anaphylactic shock occurred 5 minutes after first dose of the mRNA-1273. The event of chest discomfort, muscular weakness, gait disturbance, fatigue, and atelectasis occurred 2 days after first dose of the mRNA-1273. The treatment included epinephrine. Based on the current available information and temporal association between the use of the product and the start of the event, a causal relationship cannot be excluded..

The next morning after I had trouble getting up. I was achy and had a 99.7 fever. Took tylenol and rested. A few hours later the symptoms got worse and worse an my body ached so bad I could barely walk. The fever elevated as high as 103 during that time. And I had what felt like pressure on my neck which made my voice sounded really rough. I had chest pains, rapid HR and SOB and the symptoms got so bad I went to the ER where I remained for about 8hrs. While there I started getting a really bad headache which lasted from that Sun after to the end of the week on Friday. Benedryl, pepcid, tylenol was given. About 9:30pm I was released with a prescription for the headache and advised to take benedryl. Once home I noticed my arm was swollen and white in the center. I got a rash on that arm that carried to my face and was itchy and burning. I had lymph nodes that devoloped under both arm pits but the side where the injection was given hurt worse than the other. Had to wear the holter monitor for a week d/t the elevated HR which in turn made the healthcare specialist prescribe metroprol to help lower the HR but to date I am still having issues with the rapid HR.

Heart feels like it?s racing and then I get short of breath. Pain in my upper left chest and shoulder blade happen around the same times. It has been happening off and on since 8:30am this morning when I woke up.

The next day I had a low grade fever of 99.9, body aches, and chills. My left arm was significantly sore all day, pain from my shoulder to elbow and into my armpit/chest. On Wednesday, Jan 20th, I noticed a red mark, oval in shape, about 4 inches from the injections site that became warm to touch. During Wednesday and Thursday, the red mark got larger, wrapping around the outside of my arm and slightly swelled. It is still warm to touch but not as red today (Monday 1/25). I have applied ice to it twice a day for 20 minutes at a time.

Muscle spasms throughout body but especially in hands feet and esophagus.. possible cardiac spasms that lead to brief loss of consciousness

Day 1: Severe headaches, severe dizziness Day 3: heart palpations, continued h/a Day 6: rash at injection site, continued palpations Day 7: baseball sized rash at injection site, right arm/chest swelling, palpations Day8: severe dizziness, headaches, and continuing rash Day 10: acute rash face and neck, continued palpations

11-12 hours following the shot, I became nauseous and had a low grade fever. Heart raced over night, vomit, diarrhea, chills and aches, fatigue for 26 hours following shot.

intermittent feeling of racing heart after first dose of moderna vaccine, lasting about 2 weeks and slowly improving. also at injection site, mild itching, redness starting about 10 days after the injection

Around 730-8 I got a really bad headache. Throughout the night my back tightened up and my hips. I got up tp get ready to go to work, I felt really light headed while I was brushing my teeth but went in to work. I started felling shortened of breathe and achy. I started feeling bad and told my Head Nurse and he took my BP and I have a fever. My heart beat was rapid. I went home, slept and had no appetite . The I ended up going to the Hospital my chest was hurting bad in my lung area, everything about me just hurt I couldn't take it anymore. They did xray on my lungs, they were clear, my BP was still high, my heart rate had calmed down. They had me sit and relax. The next day I woke up and was ready to put my scrubs on, it was like nothing has ever happened to me. I felt worse with the vaccine then I did when I got the Covid, all I had with Covid headache. Everything hit so rapid and fast after the shot.

3 hours after injection severe arm pain, very stiff on movement; progressively got worse throughout night. 13 hours later SEVERE body aches worse at hips and low back, severe headache, chills with temp at 101.7. no energy and steadily declining throughout day. no appetite. Also felt very nauseous. Some mild confusion 20 hours later chest pains 01-21-2020 body aches and headache improved. Very weak and shortness of breath.

After 30 minutes of monitoring patient reported itching and feeling hot. Eeythema noted to chest. BP elevated to 160/100. Sao2 100%RA. Lungs clear no difficukty breathing. After another 15minutes BP 200/120. Patient coughing and reporting scratchy throat. No airway restriction and lungs remain clear. Facial flushing also noted. Patient left clinic after an hour of monitoring . No epinephrine given.

Developed symptoms within 10min of vaccine shot. Feeling hot and nauseous, sensation of feeling ?off?, rapid heartbeat, shaky hands. Similar to onset of more severe allergies in the past. Medical team have emergency juice and crackers and we stayed at site about 40minutes. I had some lower stomach cramps and waves of feeling strange and a bit confused and chills. It didn?t get worse but I still felt nausea and just strange, so we drove home. ( husband drove, I could not drive). About 30min into the drive we had to stop and go to a park toilet because I had sudden painful stomach cramps and the I had diarrhea (severe). Started feeling less strange and more clear headed after that. At home I took one Benadryl and Zyrtec, had more diarrhea but not severe, a bit nauseous, and felt better after 2-3 hours. No more issues after that, just a sore arm.

Reports within 10 minutes of receiving the vaccination felt lymph nodes throbbing under left arm . The pain traveled to the left elbow to the left wrist.. The next day 10:30 am, felt tachycardia, c/o blurred vision with a bad headache. Waited a bit for son to finish his activity and drove self to the Fire Station. HR was 258/minute can't remember diastolic BP but systolic BP 145. Received 2-doses of Adenosine on the way to the hospital. HR down to 145/minute in ER. Received Toradol for headache which was unrelieved. Received EKG, blood work, CT lungs. Resting HR on discharge in the 120's. 1/24/2021 Continued to feel poor with back pain making it difficult to breathe, body aches, headache and pain at the injection site. Was able to return to work on 1/26/2021

SEVERE HEADACHES, BODY ACHES AND PAINS, FEVER OF 103.9, CHILLS, SHORTNESS OF BREATH AND CHEST TIGHTNESS NAUSEA, VOMITING.

Became extremly light headed to the point of feeling like she was passing out. Hard to breathe, hot, flushed

Extreme dizziness, things pulsating with my vision, feeling of blacking out, feeling of blood rushing in and out of my head,

10 minutes after injection had tachycardia, anxiety, dizziness that lasted for about 15 minutes before resolving with some residual left cheek numbness. Had swollen area around injection site for next four days with intense itching, as well as pain ar injection site. On day 11 post vaccination, developed a rash on injection site covering the area that was previously swollen, approximately 3 inches in diameter as well as tender lymph nodes in left armpit.

She was sent to emergency room Feb 2, 2021 by her PCP after calling him with headache, found elevated BP by school nurse, 163/95, vomited x3, left hand numbness but resolved upon arrival, decreased vision brief right visual disturbance. denies fever nasal congestion, sore throat, cough, chest pain. EKG NSR 95, head CT-no acute intracranial abnormality, UA and blood work completed

Flu like symptoms, elevated heart rate, slight dizziness, weird vision, slight fever one day, anxiety, weakness.

1/26/21: 1-2 hours post vaccine- fatigue and heavy body 1/27/21: 5 am woke to extreme headache/migraine. Could not lift my head off the pillow but also could not sleep. Body aches began all over but especially in lower back. Chills and fever that went on and off throughout the day, peeking at 103 degrees. Spent the entire day in bed. Extreme fatigue and heavy body. Noting slight lift in symptoms enough to get up and eat dinner but then went right back to laying down. 1/28/21: Extreme fatigue and heavy body. Moderate headache. Heart rate racing. Dizzy. Sweating profusely. 1/29/21: Moderate fatigue and heavy body. Moderate headache. Heart rate continues to race. Resting heart rate over 100 bpm just laying down. Dizzy. Brain fog. 1/30/21: Slight headache. Fatigue and heavy body continue. Heart rate fluttering and elevated. Dizzy. Brain Fog. 1/31- 2/3/21- Fatigue. Heavy body. Dizzy. Heart Rate elevations and fluttering. Brain Fog. All other symptoms have dissipated.

Symptoms immediately following the vaccine on Wednesday; tachycardia, shortness of breath, dizziness. Symptoms the following day on Thursday; tachycardia, shortness of breath, weakness, fatigue. Symptoms on Friday; tachycardia, shortness of breath, weakness, fatigue, diarrhea, cough, loss of control of extremities, debilitating headache, nausea, dizziness. Symptoms on Saturday; chills, tachycardia, shortness of breath, weakness, fatigue, diarrhea, cough, loss of control of extremities, debilitating headache, nausea, dizziness, blurred vision, sensitivity to lighten and sound, sore throat, stuffy nose, ringing in ears. Symptoms on Sunday to current 2/3/21 tachycardia, shortness of breath, weakness, fatigue, diarrhea, cough, loss of control of extremities, debilitating headache, nausea, dizziness, blurred vision, sensitivity to lighten and sound, sore throat, stuffy nose, ringing in ears.

Chest pain, palpitations, severe headache, chills, fatigue X33 hours, severe headache 9 days later as well on 02/03/2021 at 2300 hours.

12 hours after the 2nd vaccine, I experienced severe dizziness, body aches and fever. 17 hours after the vaccine I experienced a heartrate in the 150's, fever, chills, sweating and shortness of breath. 24 hours after i still had a fever, hr was 110 at rest and oxygen 99% at rest. While walking HR increased to 120's and oxgen saturation decreased to 86%. This persisted throughout the day.

Sinking feeling, hollowness in chest, lightheadedness. No dyspnea, rash, itching, or swelling. Vitals stable (BP 126/89, HR 84, pulse ox 98-100%) Patient reports that she has had very similar symptoms after methlparaben, although those were more severe. She does not feel that she needs additional medical attention, declined ED visit.

Ten minutes after I got my vaccine myarm burned, I felt warm, flushed, and my heart rate went into the 90s. Normal resting is 62. The feeling calmed a little and then came in waves. After about 20 minutes after the vaccine my blood pressure was 154/110., usually it?s normal or low. We tried an ice pack on my neck and then went outside to cool off. The nurse called my doctor and he said to take Benadryl. The cool air and Benadryl calmed down my symptoms and after about an hour my blood pressure was closer to normal and was feeling more like myself. About 6pm all of a sudden I had aches all over, felt nauseous, extremely tired, and felt ill. That lasted about 36 hours.

Patient received vaccine in left deltoid at 3:40PM. During observation she became dizzy and fainted in seated position at 3:50PM. She came to immediately with the pharmacist talking to her and grasping her shoulders. Her BP at 3:51PM was 120/83 with HR of 60. Patient admitted to fasting for two days prior. She was administered Glutose gel sublingually at 3:54PM and BP was 107/81 with HR 69. She began to feel less faint with color returning within 2 minutes of administration of the glucose. She was observed until 4:10PM without any further incident. She was released with pharmacist's recommendation to go to the ER if any other symptoms are experienced.

Patient complained of dizziness at 1041 am in recovery area, escorted to cot via wheel chair and assisted her to lay down. Pulse 72, gave water, no complaints of difficulty breathing. Pulse ox checked, 99%. Patient started nausea with some dry heaves, remained alert and oriented. Began to complain of chest pressure and squeezing feeling in head. 911 was called 10:59 Bp 124/82, Hr 92, pulse ox 99. Assessed patient, says she is starting to feel better Refusing to go to hospital. Advised patient not to drive and awaiting a ride from friend.EMT left at 11:30. Feeling better at 1145.

Patient first had lip tingling 5 minutes after vaccination, but no changes in respiration. Patient began to develop hives 2 hours after vaccination. She came down to pharmacy. She was given 1ml of diphenhydramine 50mg/ml. Measurements of her blood pressure yielded very high readings. Called EMT due to high BP readings.

Started having nausea, vomiting, diarrhea, palpitations, myalgias, dizziness, fever of 100, arm heavy on 2/3/21. Had second COVID vaccine on 2/2/21. Went to Urgent care on 2/3/21 and diagnosed with Non-intractable vomiting and acute diarrhea.

42yo G2P0010 at 3+6 weeks GA by LMP 1/1/2021 with EDD 10/8/2021 on day of Vaccine Dose #2 (1/28/2021), positive urine pregnancy test on 1/30/21. Bleeding began on 2/4/2021, and complete miscarriage occurred on 2/5-2/6.

MODERNA COVID-19 vaccine EUA Received first shot yesterday (2/10/21 @ 2:42pm) had chills off and on overnight and sore arm. Got up at 6:30 am today (2/11/21), used the bathroom, felt very dizzy and lightheaded, started sweating profusely, tried to make it back to bed, took 4 steps and passed out, hitting my face on dresser. This has only happened one other time, 16 years ago when I was pregnant, flying on vacation and hadn?t eaten, blood sugar dropped and I passed out momentarily. No history of fainting, not diabetic, no health issues whatsoever. Healthy weight, fit and in shape.

2/10-Chills around 2:30 am (did not take temperature); fainting spell around 7:00 am and temp of 100.1; chills, fluctuating temperature (99.5-100.1), sore arm, redness at injection site, and fatigue all day. 2/11-mild arm soreness, redness at site injection, and temperature between 98.4-99.6 (higher than normal for me. I take my temp every day for work and am usually 97.3-97.8).

Immediate feeling of tahycardia, numbness in feet and feeling of passing out after injection. My immunologist believes that this was a cytokine storm reaction (non anyphylaxis). Store gave me water and cookie to help. Discomfort continued. Paramedics were on site and did work up on me and allowed me after 1 hour to go home where fever and chills continued for 2 hours. Immunologist would like to administer second dose in her office using desensitizing approach.

During first week experienced episodes of rapid heart beat randomly. 1 week post injection developed a hard ball with small scab. Scab/ball expressed small amount of blood and began weeping. Covered with a band aid over night. Skin in area became raised and red. Appeared to have burned and developed a scab about the size of a quarter. Slow to heal; scabbed for 2 weeks. Scab came off leaving the area red a raw. Very irritated with itching, intense at times. Week 3 remains raised and red. Improved with OTC Hydrocortisone, but sites remains with itching. Appears to be scaring.

Minor upper lip swelling around 30 mins after injection. Could have been from wearing mask 2:41 pm. Migraine level headache, followed by chills and nausea. Went away with advil and an hour nap. Around 6 pm. A hive on collarbone and one on neck. Puffy upper lip. Occasional racing heart feeling. Severely itchy ears, inside of mouth, face, and neck. Took Benadryl and symptoms cleared within 30 mins. Random headache, chills, joint pain, and minor itchy skin throughout the weekend.

On 1/31/21, 8 days post vaccine, I noticed bruising on my torso and left leg. Over the course of the next three days I noticed more bruising on my arms, elbows, legs, and knees. At 11 days post vaccine I had a telehealth doctor visit and she ordered a CBC blood work panel to test my platelets. At 13 days post vaccine I was notified that my blood work panel revealed extremely low platelets and I needed to see an adult medicine doctor immediately. My primary care doctor referred me to a hematologist for immediate treatment.

The staff member was given a Covid-19 vaccination as part of the LTCF Covid-19 clinic scheduled on 2/25/2021. During the 20 minute observation period the patient lost consciousness and begin to have seizure-like shaking. An 0.3mg epi-pen was administered in the lateral thigh. The patient then experienced cardiac arrest at which point nurses from the LTCF began and completed 2 cycles of CPR before the staff member was resuscitated. EMS arrived and assessed the patient. Patient was taken to the hospital for further evaluation.

Patient has history of immunocompromised. Discussed vaccination with provider prior to vaccination. Client vaccinated with Covid 19 vaccine at 9:50 AM and advised to wait 30 minutes. At 10:00 am client c/o feeling light headed and dizzy. Client appeared pale. C/o scratchy throat. BP 110/70, Pulse 78, regular, RR 18. Client laying on cot. 10:05 client given Benadryl 25 mg po. 10:10 client c/o chest redness. Denies breathing difficulty or numbness or tingling. Throat feels "funny", not scratchy. 10:15 am BP 130/80, Pulse 86, regular, RR 20. 10:20 am Throat no longer feels "funny or scratchy. 10:25 client sitting in wheelchair. 10:30 BP 148/86, Pulse 86, regular. 10:45 BP 130/78, Pulse 88, regular. 11:00 client states she is feeling ok with no more allergic symptoms. Client went home for day. Phone call to client at 1:00 pm. Left message. Text from client at 3:12 that she is no longer experiencing any symptoms, except exhaustion.

Chest pain, fever (102.7), dizziness, exaggerated body pain, metallic taste in mouth, not able to walk, not able to stay awake for more than a few minutes, swollen lymph nodes under armpits on right arm

Immediately after receiving the moderna vaccine I felt a warm feeling in my arm and immediately in my chest and my heart rate increased immediately and I felt a little dizzy. After abt 5-10min my heartrate slowed down. EMS was on site and performed bp check and Ekg which he says were both textbook and normal. My hear rate at that point was at 100bpm.

Had the injection Friday evening. Very quickly had my heart rise and felt shaky (like when you take an inhaler). Heart rate stayed up for about 30 min, shaky for about another 1 and half. but left factily after 15 minutes, as I was shaky, but ok. About 20 min after shot, the tip of my tongue and lips got tingly/numbish. Not swollen, just tingly. (They were very slightly the same way the next day). I went home and contacted hotline. She suggested I call a dr. I called a dr who told me to take a benadryl. I ate some food and took the benadryl. I fell asleep and slept for 14 hours (definitely not normal). That next day (Saturday) I had a headache, upset stomach, lowgrade fever (below 99.9) and pretty good pain in the injection arm. Stomach was settled by that evening, headache was gone Sunday. Off and on low grade fever (highest was 100.3) still ongoing (Tues 3/2, but highest today is 99.1))

anaphylaxis - throat tightness, hoarseness, coughing, trouble swallowing, nausea, dizziness, pallor, watery eyes, urinary incontinence, sense of impending doom

Whole left arm hurt Severe headache 104.5 fever Passed out 2 different times Chills Delerious Lost control of bladder twice Seizure Breathing difficulties-responded to use of inhaler

woke up at 2 am (March 3) with racing heart, headache and bad dreams.....awoke again at 7 am with heart racing and headache. Flu like symptoms started at 11 am and lasted throughout the entire day

Starting on Sunday Feb 28th I was very fatigued. I woke up on Monday after sleeping more than 12 hours with my head feeling tight and hot. My eyelids were burning, the skin around my neck felt irritated and my lymph nodes in my neck were swollen. The burning in my eyelids and neck pain went away by Monday evening. However on Tuesday I woke up with a visible rash on my neck. In the last few days it has stayed even though I have applied cortisone and neosporin on it. It is now warm to the touch and itchy. I also have a rash on my eyelids and my cheek which are hard to see in pictures because of my skin tone. I called my Primary for a virtual consult when I woke up this morning Saturday March 6 because I am feeling itchy all over especially on my back. Additionally, the skin of my elbows and knees (in the joint crease area) are now super warm like my eyelids were before the rash appeared. I also have neck pain again which started yesterday (March 5th) afternoon. It is not a muscular pain. It starts at the base of neck and radiates up to the crown of my head. It has not gone away with either Tylenol or Advil. My chest is also tight--not my lungs but my chest itself.

Guillain Barre Syndrome that lasted for 4 weeks. Prickling, pins and needles sensations in arm, fingers, leg, feet numbness/loss of feeling in arm and hand for weeks Difficulty with facial movements, including speaking, chewing or swallowing Severe pain, achy, shooting or cramplike Rapid heart rate Difficulty breathing

On 2/26/2021 shaky. shortness of breath, pressure in chest, felt like something was squeezing my throat, and cold chills off and on all day and night. On 2/27/2021 previous symptoms, exhaustion, and achy body. On 2/28/2021 previous symptoms, nausea, light-headed and dizziness. On 3/1/2021 previous symptoms, vomiting, headache, weakness to stand or walk, faintness--felt like I was going to pass out, eyes dilated, I don't remember a lot that happened that morning, taken by ambulance to the hospital, treated for dehydration and sent home later that day to rest--followed up with family physician on 3/4/2021 still feeling the above symptoms. I've been feeling exhausted, and the previous symptoms.

Systemic: Dizziness / Lightheadness-Severe, Systemic: Fainting / Unresponsive-Severe, Systemic: Flushed / Sweating-Medium, Systemic: Tingling (specify: facial area, extemities)-Medium, Systemic: Vomiting-Severe, Additional Details: Approximately 5 minutes after administration of moderna vaccine, pt reported feeling hot to observer. RN came out to check pt and pt then rolled eyes to left and back and passed out in chair. RN helped pt to sit upright in chair as was about to fall off chair. After 10 seconds patient able to talk with patient. She stated she still felt tingling in arms but cooling down. Had additional tingling/warm and vomitting episode. Paramedics called. Pt refused transport, parent going to drive to ER.

DVT blood clot and surface blood clot in lower left leg diagnosed at the ER on 2/12/21. Levonox injections and warfarin have been started. Twice weekly INR checks. No longer need the injections; warfarin is continued. Next INR check is scheduled for Thursday March 11, 2021. Warfarin may need to continue life-long.

11:39Chest tightness, clients albuterol inhaler- 11:58 feeling the need to "clear throat", dizziness, leg weakness increased heart rate 25mg benadryl. symptoms resolved at 12:42

patient developed redness on chest. patient felt dizzy , hot then felt cold. patients blood pressure was elevated. The patient wanted to be checked out EMS was called and patient taken to the hospital

Brain fog, fatigue, rapid heart beat, headache, late period, spotting mid cycle, pain in arm, joint pain

Patient taken to the ER; Palpitation; Light headedness; Tingling sensation on hand and feet; Rash; Nausea; Fever (low grade); Chills; Server allergic reaction; A spontaneous report was received from a 43 years old female patient concerning her self who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events nausea, palpitation, light headedness, rash, tingling sensation on hand and feet, fever (low grade), chills, was taken to the ER. The patient's medical history was not provided. No relevant concomitant medications were reported. On 19 Jan 2021, at around 3:50 pm, prior to the onset of the events the patient received their first of two planned doses of mRNA-1273 (lot/batch: 041L20A) intramuscularly at unknown anatomical region for prophylaxis of COVID-19 infection. On 19 Jan 2021, about 7-10min after receiving the first dose of mRNA-1273, the patient experienced had palpitation light headedness and nausea. The patient was evaluated at vaccination post asked to go home. At home, the Palpitation continue (HR=150b/m in) and had rash and tingling on her hand and feet. The patient was taken to the ER at around 8:30-9:00 pm. At ER the patient was given IV fluids, Ibuprofen and acetaminophen. EKG was done and was normal, the patient was released to go home with a HR of 105 b/min. Since then she had repeated episodes of palpitation, fever (low grade) and chills. On 26 Jan-2021, the patient experienced the servere allergic reaction a week later after receiving the Moderna Covid-19. The Patient consented to be followed up by the safety department. Patient had been advice by her physician not to take the 2nd dose of the vaccine on 28 Jan 21. Treatment details included IV fluids, Acetaminophen, Ibuprofen Action taken with mRNA-1273 in response to the events was not reported. On an unknown date the outcome of events include nausea, light headedness, rash, tingling sensation on hand and feet was unknown and Palpitation, fever (low grade) and chill was not recovered.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.

Headache from back of head down to back of neck almost an hour after injection. Continuous waves of pulsing headaches behind eyes and by temples of head with increase blood pressure, and nausea since injection til current. Committed at 1pm Thursday. Loss of appetite since Wednesday. Lower back pain on Wednesday.

Pt reported chest pain/tightness immediately after vaccination. BP was 210/127, HR 88, 02 100% on room air. Pt rated her pain at 5/10. Stated that was on BP medications but was non-compliant. Pt was monitored by the administering nurse and FD captain and an ambulance was called for the patient.

The injection area on my left arm started itching really bad starting at 9pm on Sunday March 14th 2021. Then by the time I went to bed my entire body started itching. I woke up at 2am. I took 50mg of Atarax, then I took 50mg of Atarax on Monday morning. I developed a rash on my wrist by Monday morning March 15th 2021. I still was itching like crazy on Tuesday even with taking the Atarax pills. I called my family Dr. on Tuesday afternoon and told her that I was itching like crazy all over my body even with taking the Atarax. I was concerned taking Atarax because it was making my hear rate go up. She told me to go to the ER at, so I went to Emergency Room.

Moderna COVID-19 Vaccine EUA..... Symptoms began at 5am on the morning of 3/17, swelling of the tongue and lymph nodes, also sweeling on left side of face by the ear and jaw. Headache, elevated heart rate, weakness

EDC: 25 APR 2021 AE1: Superficial Venous Thrombosis: On 10 Feb 2021, patient presents with RLL pain and swelling. Dopplers with non-occlusive Superficial Venous Thrombosis. Started on 40 Lovenox qd. On 23 Feb, had worsening pain and repeat doppler showed occlusive SVT. Her Lovenox was increased to 40 mg BID and referred to Hematology. Her hematologist increased her lovenox to 80 mg bid. SAE: Pulmonary Embolism: On 3/9 patient developed Shortness of breath and chest pain and went to ED where she was diagnosed with Bilateral pulmonary emboli. She was admitted to the hospital and started on an heparin drip. AE2: SVT: Patient developed a second SVT after discharge from hospital on 17 Mar 2021 that is located away from original SVT site.

Passed Out; Possible Seizure; Swollen Tongue; itchines; Headache; shivering; shaking really bad; A spontaneous report was received from a nurse who was a 42- year-old, female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and who experienced shivering, shaking really bad, had a headache day afterwards, tongue was swollen, passed out and doesn't know if she had a seizure and itchiness. The patient's medical history was not reported by the reporter. Concomitant medications were not provided. On 19-Jan 2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Lot number: 039K20A) intramuscularly for prophylaxis of COVID-19 infection. On 20-Jan-2021, 24 hours after vaccine administration, the patient reported that she was shivering and shaking really bad and had a headache day afterwards. On an unknown date, she reported that her tongue was swollen. She also reported that the she passed out and doesn't know if she had a seizure (date unknown). The patient reported that she took ibroprophen for her headache and diphenhydramine for itchiness. On 28-Jan-2021, she reported that she felt fine. Treatment for events included ibroprophen and diphenhydramine. Action taken with mRNA-1273 in response to the events was unknown. The outcomes of events, experienced some side effects was unknown, shivering, shaking really bad, had a headache day afterwards, tongue was swollen, passed out and doesn't know if she had a seizure and itchiness, were considered recovered/resolved on an unknown date.; Reporter's Comments: Based on the information provided and a strong temporal association between the reported events and administration of mRNA-1273 vaccine, a causal association between the reported events and the product use cannot be excluded. Headache and chills are consistent with the known safety profile of the vaccine

Jan 14: Shot #1 of Moderna at 7 am at Hospital o Very sore at injection site for 2-3 days o Retrospectively, I recognize a subtle shift in my mood after the first shot that has persisted. I felt inexplicably sad in the afternoons and continued until March 1st anxiety event. I also found myself crying more. o Sleep ? I woke up a handful of times with heart racing and then would fall back asleep. This is never had happened before February 11: Shot #2 of Moderna at 7 am at Hospital o Within 11 hours of the vaccine had fever, chills, aching and 103 fever. Next day my period started a week early. o Over the course of the next two weeks my anxiety levels heightened; o March 1st acute event that mimicked an anxiety attack (no previous history of anxiety or attacks); followed by my first night of many nights with no sleep. o Insomnia ? worsened each night. o Internal thermostat dysregulation ? I would get very cold and shake uncontrollably and then feel hot after the shaking episode; shaking would often happen in the afternoon and especially after meals. o High Blood pressure o Night sweats. o Muscle weakness; tingliness running through arms and legs. o My heart would skip a beat (several times a day). o My entire body would feel like it was pulsating uncontrollably but I wouldn?t be visibly shaking. o Muscle stiffness. o Pain in lower right back region (ultrasound yielded nothing). o Extreme exhaustion. o Loss of appetite and dietary changes (no longer can eat rich foods; only bland small meals multiple times a day) o Weight loss (5-6 pounds) in one week (146-140) o Unable to focus; blurry vision. o Unable to partake in intense physical activity; can only walk. o Unable to participate in household work because of low energy. o Unable to participate in job duties due to inability to focus on screen for long periods of time. o. Second week, March 8th, muscles in upper back burn and intense pins and needles in my shoulders arms to finger tips. T This sensation woke me up from sleep on Friday March 12th. o Unable to focus; blurry vision. o Strange headaches- behind eyes, in temples, on one side of the head. (don?t? have a history of headaches)

Went into SVT with chest pain the next day after receiving second vaccine. The patient was cleaning her bedroom.

THIS WAS MY FIRST DOSE OF THE MODERNA VACCINE: 5 minutes after I had the vaccine, I started feeling off. I felt completely out of it, I went pale, shaking. The EMT's were with me and checked my pressure. It was through the roof. I'm otherwise a healthy person with BP regularly of 120/80. My BP at 3:20 PM -- 148/96 3:35 pm - took one 25 mg of Benadryl. 3.45 - BP 139/92 3.52 - BP 122/88 3.55 - Took a SECOND benadryl pill 25 mg. (throat felt heavy when swallowing) 4.20 - BP 120/82 EMT stated that it was an ALLERGIC REACTION cause VASO VAGAL SYMPTOMS. My throat felt swollen (I have NEVER experienced this before). I was sitting in the car for almost 2 hours before I felt somewhat comfortable to go home. My husband drove me home.

I could feel the vaccine enter my body & feel it move up my arm & spread up across my back & up my neck. I was nauseous instantly. After 15 minutes I felt dizzy & weak. I started to twitch all over as the vaccine moved through my body. Later that day I had excruciating pain in all my joints & muscles & even bone pain. I got a headache. I felt sharp shooting pains in my chest. 2 days later intense nausea set in. I almost passed out. I am fatigued. I had strange abdominal issues like pressure, bloating, intense cramping, heartburn. I don?t have much of an appetite. I am fatigued. I had diarrhea.

1st Moderna shot was 1/4/21. Had a syncope episode/potential seizure on 1/13/21 - unwitnessed loss of consciousness for a short period of time with loss of urinary continence. 2nd Moderna COVID shot on 1/29/21 with no reactions. My doctors evaluating me did not consider this as a COVID vaccine reaction, even though it did occur after the first vaccination. I am a nurse with a doctorate degree and do not believe the seizure was the reaction of the COVID vaccine. I was under extreme amounts of stress at work at the time. I also have a prior medical history of syncope episodes when I was a teenager (25+ years ago).

1st dose, 12:10 pm pt c/o feeling flushed, rapid pulse, cold legs and body, funny taste in mouth, light headed, and nauseous. BP 140/80 HT 84 O2Sat 99% , Repeat VS 140/80 HR 72 O2sat 98%. Pt reports history of allergy to Augmentin, with hives. Denies anaphylaxis. 12:15 PM pt reported feeling a little better. Pt declined EMS evaluated that was offered. Pt signed Chesprocott refusal form and was given ED precautions. Pt was advised to contact her PCP this afternoon. Pt?s husband who was present the entire time will drive the pt home.

Patient received vaccine at approximately 8:55 am, patient says she called her sister, and then her husband. After she got off the phone, about 7 minutes after her injection, she started to feel like she was going to faint, she then put her head between her knees like she normally does when she gets that feeling, and then when she came to, she felt better. The patient had blown her horn, so an EMT and nurses were able to assist her right away. EMS was called to check patient for her syncopal episode.

Weird headache at top of head which would come on quickly for a minute or two then vanish and repeat every 10-15 minutes or so. Very tired. Had started menstrual cycle on March 17, but post vaccine it was lighter than normal and then on the 22nd it became very heavy and there were lots of large blood clots. This has lasted an additional three days. My cycle usually lasts 5-7 days but day 2/3 are the heaviest and it?s usually very light by day 6/7. I have not had blood clots in several years. These are very large.

Inability to move within 24 hours - lasting 48+ hours Vomiting Pain in left (shot) arm radiating to left breast Rash Headache on the first day Chest pain/tightness, consistent shortness of breath, worse with exertion Brain fog Fatigue Inability to concentrate Very acute depression in the first 3-4 days after the 2nd shot

felt facial flushing later that day, felt unstable on legs, felt like would buckle, pains in legs--sx has improved but still feeling it for next 3 days, felt very tired then head to toe, felt tightness in muscles--sx has improved then having hard beating of heart; also beating fast; also fluttering, feeling dizzy--worse with exertion feeling SOB

Extreme nausea and headache, dehydration, body pains, weakness, inability to move easily from bed, care for children, drive. Chest pain and heaviness.

Per ED report, patient went to Pharmacy to get her 2nd COVID 19 vaccine on 3/29/2021 ~ 1 pm. She first felt fine, but ~ 2 pm she started having breakout of her rash, a dry cough and slightly raspy throat as well as facial swelling. She came to the Outpatient Center where she usually receives Xolair for her idiopathic anaphylaxis q 2 weeks, where she received a total of 300 mg of IV diphenhydramine and 40 mg of IV famotidine, after which they sent her to the ED for further observation and medication administration. Per ED note, allergic reaction/early anaphylaxis after 2nd COVID 19 vaccine, but no severe anaphylaxis or hypotension noted; no evidence of acute pharyngeal edema. In the ED pt was given 2 doses of epinephrine IM and further diphenhydramine. Later she was admitted for observation and further epinephrine and diphenhydramine administrations. She was discharged on 4/1/2021 in stable condition.

Brother called pharmacy on 04.13.2021 at approximately 10am and informed pharmacist that his sister had passed away due to a pulmonary embolism about 2 weeks after receiving her first dose of the Moderna COVID vaccination at our pharmacy. He mentioned that healthcare provider was looking at possible gene mutation in family that may have contributed.

OS 42 Y.o. Female AAox4, anaphylactic reaction. translator was used. Pt complained of extreme difficulty breathing, swollen tongue, difficulty swallowing. Pt was out side of vehicle pacing back and forth in distress. Prior to epi admin pt. Was having near syncope also. Pt. Appeared pale in color and distressed, pacing back and forth with anxious look on her face. Pt pulse rate also was approx 110 prior to administration, and strong. RR was approximately 20. Bp 186/92 post administration. Tx. Pt was examined and verbal interview conducted through interpreter. EMS summonsed. Pt advised tongue was starting to swell significantly, and increase in SOB, nausea and. Near syncope. Pt administered 0.3 mg epinephrine through autoinjector to r thigh @ 1128. Pt advised after approx 6 min post injection that tongue swelling was decreasing and she was able to breath again and was not having near syncopal episodes. Pt care transfers to hospital with a non-emergent transfer to hospital.

severe upper back pain with increase in pain with movement of my neck radiating between shoulders pain in the upper thoracic with walkiing and raising arms tingling in the upper back bl

Pt with urticaria, swelling to face and itching to mouth that occurred within 10 minutes of administration. She was treated with benadryl 50 mg IM upon onset of symptoms. She did not have any stridor, hypoxia, or tachycardia or hypotension. She did have a change in pulse from 70s to 100 then back to 70s 10 minutes after administration of benadryl and stated she has a paradoxical reaction to benadryl. She experienced pallor and livedo after administration of benadryl which resolved after 15 minutes. She experienced urticaria on 01/01/21 into 01/02/21 requiring continued antihistamines which did subsequently improve.

I felt weak, my heart rate went up to 120's, my SBP went up to 150's, I had SOB and felt I was thirsty and I need air and I had severe headache few minutes about 5 -20 minutes after I had shots. I took Ibuprofen for severe headache and sore on my Left upper arm at the injection site. Yesterday 1/2/21 I observed at the injection site has some redness in circular area, warmth to the touch and slightly sore. I met my PCP last 1/28/20 and had my physical exam.

Irregular heartbeat and hives 10 minutes after receiving the injection. Treated with Benadryl. Resolved 8 hours later. Pain and swelling at injection site, chills, muscle and joint pain, headache and fatigue. Treated with Ibuprofen. Resolved 24 hours later.

I started with fatigue on 12/24/20 and on 12/25/20 developed fatigue and chills (could not get warm). On 12/25/20 I was walking downstairs when my husband felt I didn't look normal. I fell off the bottom two stairs sustaining injury to both feet. I was able to get myself up to standing position and then sat down. My husband reports that a few minutes later I had what he described was seizure activity for about one minute/stopped breathing and he called 911. Due to COVID visitor restrictions my husband was not allowed to go to the ER with me the night of the incident. I had full work-up with labs, EKG and head CT that were unremarkable at Medical Center. I had an appointment with my primary care physician on 12/28/20 and was referred to neurologist. He did an exam, ordered MRI and sleep deprived EEG. My MRI was completed and reported as no abnormalities. I have the sleep deprived EEG scheduled on 1/11/21. I have continued pain/physical therapy on both feet/ankles from the date of the incident.

Had severe chills when I went to bed. Woke up around 1:45am with severe pounding headache, fever, body aches, heart racing. 911 was called for fear of getting worse, however vital signs were stable so I stayed home and declined visit to ER. I had COVID in September

Dizzy, lightheaded, extreme tingling in arms and hands, tingling in the face, numb tongue, heart palpitations, feeling faint, blurred vision, shaking

(R) lung region- Persistent dull pain, with sharp pain present when taking deep breaths, yawning, coughing, sneezing. Occasional mild chest tightness on (R) side upon exertion. No shortness of breath, no respiratory labor. No dizziness / headaches noted. No sided weakness, general fatigue noted. V/S= 115/68; 97.5; 68; 19; 8/10 (to affected areas mentioned); O2= 99% in room air.

Headache, Myalgia, HYPERtension, Angina, bilateral hand swelling Narrative: vaccinated in R) arm reports pain went down right arm into forearm and had bil hand swelling. Reported soon after chest pain and headache. BP elevated 190/122 P 64 did come down to 152/91 P 65. EMS called to transport for work up.

NauseaVomiting & HYPERtension Narrative: nausea and elevated blood pressure 141/91; reclined in chair for 10 minutes; nausea resolved and BP decreased to 127/82.

Approximately 2 minutes following the injection client complained of "tingling" in mouth and lips. No visible "rash/hive" or swelling present. Able to swallow without difficulty. Vital signs within normal limits except for b/p noted as 150/110. States b/p has been elevated prior to this time. Oxygen saturations remained at 99%. Noted as being "hot" no flushing observed. Chewable Benadryl 50 mg administered and EMS contacted. Patient stated during this time that she had previously taken inhalers (both albuterol and steroid) prior to the clinic and admitted to having chronic breathing problems. Referred to Emergency Department. Refused ambulance and was taken to ED by private car.

This morning Friday 1/8/21 pt was given injection at 0912. At about 0930 pt C/O diaphoresis, lightheadness. Water was offered. BP taken manually in 80s. 911 was called. Pt suffering substernal pain. A/OX4 no fainting. Paramedics arrived at 0940, assessed pt and EKG performed. Paramedics encouraged for pt to go to her hospital, Pt declined and exited clinic on her own.

The patient had a previous reaction to a flu vaccine. She was treated for Bell's Palsy related to the flu vaccine 3 years ago. The patient with the moderna vaccine started feeling left arm weakness and the arm felt heavy. She was unable to lift arm. She had a lump in her throat but minimal difficulty breathing and swallowing. She then reported right arm weakness and being unable to move either arm. She was having episodic type reactions. Every few minutes she would lose color and appear to be having difficulty breathing and swallowing but would come back to normal within a minute or two. After the 4th episode in which she stated she was going to pass out and could not move her legs, we had EMS called to come monitor the patient. EMS took vitals and monitored for and additional 20-30 minutes. The patient refused to leave with EMS and I continued to monitor for a short time longer for the duration of about 1.5 hours.

Patient received vaccine at 951 then presented back at clinic at 1100am. Presented with flushing, followed by clammy feeling and slight rash, tachycardia about 1 hour post vaccination. Patient was given Benadryl 50mg, Solu- Medrol 125mg and Pepcid 20mg on 12/30/20 @ 1120

Painful left arm starting 4 hours after injection, not yet resolved at 53 hours (improving). Low grade fever, chills, malaise, fatigue, joint and muscle pain, nausea, racing heart rate with mild exertion, all starting about 10 hours post vaccination, waxing and waning at 53 hours, slowly improving.

Sever thrombocytopenia (platelet count 2,000) 8 days following Moderna COVID vaccine. Clinically suspicious for ITP.

Patient received COVID-19 Vaccine at 0956 and reported symptoms of itchy face and chest pressure at approximately 1008 during observation period. Pt vital signs were 133/86, HR 130 and oxygen saturation 100% on room air. Pt reported worsening symptoms of chest pressure and itchiness to face. Provider instructed Epi Pen be given and pt to be transported to ED for further evaluation. EKG obtained and showed sinus tachycardia. Nonrebreather oxygen mask applied with 2L/min and oxygen saturation remained at 100%. Pt was transported via ambulance to at 1038 and pt reported feeling improved symptoms prior to leaving the clinic at approximately 1034. Pt stable at time of transfer.

Within 5 minutes I felt severe tightness pressure in lungs area & chest. It has been 24 hours and I?m still feeling the same.

Difficulties breathing within 5 minutes of getting the vaccine, Lightheaded, fast heartbeat, pain on the arm of injection. Within 1 hour: headache, tiredness, swelling on the site of the injection.

I was fine the day of the vaccination. I started feeling bad overnight - got a headache and arm got sore. When I woke up in the morning to get ready for work I felt very weak. I walked into my bathroom and lost conciousness. I woke up on the floor and had hit my forehead on the tile floor. I was confused when I got up, and proceeded to get into the shower. I then passed out again in the shower and hit the back of my head against the shower wall. My husband found me as I woke up on the shower floor. He called my doctor and took me to the emergency department on doctors advice.

"Moderna Covid-19 Vaccine EUA" No problems the day of the vaccine. Overnight I developed a sore arm, chills, and headache, which I expected. The next morning I got up to get ready for work and I passed out, hitting my forehead on the tile floor very hard. I woke up on the floor, then got in shower and immediately passed out again, hitting the back of my head on shower wall. My husband found me sitting on shower floor still groggy. He called primary care provider, who said to take me to emergency department. He took me to emergency department.

Moderna COVID-19 Vaccine EUA Around 4pm on January 14th, left upper arm began to swell and feel sore, becoming very painful, radiating down left arm and up left shoulder and had pins and needles in my left hand and could not really lift my left arm. Around 5pm I began developing a headache. At 6:30pm I developed a 101 degree fever, and took ibuprofen 600mg, my headache was more severe, I had chills, body aches and my left clavicle became swollen. My heart was pounding and I felt short of breath. The racing heart and breathing resolved by 8pm. By 1am on January 15th my fever was 101.8, I had significant swelling in my left arm, left shoulder, back of my neck, upper back, and back of my head. I had a severe headache. I took ibuprofen 600mg at that time. The swelling improved by 3am. By 8:30 am my fever was 100.7. I took 600mg of ibuprofen again and by 9:30am my temperature was 99.8 degrees. I continue to have a mild headache and fatigue.

Tight chest, shortness of breath, welts, red rash, swollen tongue, swollen bottom lip, itchy body, itchy mouth and throat, fatigue, tingling on legs, arms and hands

Was seen in the ER with chest pain, elevated pulse (130?s), and B/P 170/80. At this time 1/16/2021 I am still having intermittent chest pain

received vaccine at 1140, by 1630 I felt flushed, and light headed, and slightly hypotensive at 98/56, over night I spiked a fever rangeing from 99.8-100.8, with chills, dizziness, generalized fatigue and body aches, some sob w/ activity, and speech, some tachycardia w/ a hr 115-125, I was unable to report to work 01/15/2021, sxs did not improve until late afternoon 01/17/2021, was able to return to work 1/18/21 with continued sob w/ exertion, generalized body aches, and fatigue

On 01/08/2021 I received the 1st Covid-19 Moderna vaccine at 1:45pm. At 2pm felt a warm feeling go through my body. At 2:10pm My heartrate went up and felt pain go from right arm into my neck. At 2:15pm I stood up and Heart rate went faster and felt it in my head Pulse was 138. At 2:25pm Pulse went to 152 and bounced between 115-140's. At 2:35pm Blood Pressure was 157/110 and my chest felt tight. I was feeling dizzy. 2:45pm was put in another room, Still I didn't feel well. At 3:15pm moved to another room they did an EKG it showed sinus tachycardia. 3:45pm went home. 4:pm discovered hives. I also got flu like symptoms for 3 days and a lot of pain and swelling of arm. I also got SOB and chest tightness, Which I

8 mins after receiving first dose, I became very dizzy, my heart rate increased and I started sweating. I never passed out and remained sitting. The episode lasted 1-2 minutes. I did not need assistance. Then 2 -3 hours later I had the exact same episode and reported it to the downtown clinic and they only urged me to self monitor or report to ER if needed. Those were the only 2 episodes. My blood pressure was elevated that afternoon but was very low for 3 days and I did not take my atenolol for those days.

24 hours after vaccination I had tingling and numbness on right side of face, heavy eyelids, "pulling sensation" in neck. Unable to lay flat. Tingling and numbness would switch from right side to entire face but mostly on right side. Headaches and noticed increased heart rate two days after vaccine. One week after vaccine numbness and weakness extended down right arm and leg, able to move leg just felt "weak". I thought I was having a stroke or TIA. Made an appt. with the NP and she did full neuro exam and everything came back normal. Also, made an appt. with my PCP. Still continued to have headaches and weakness improved. Did get a COVID test since was still having headaches and it so long since vaccine, received test 1/12/2021 and it was negative. This past weekend was the 1st time I felt "pre vaccine" 17 days post vaccination. I am truly hesitant to take my 2nd dose scheduled on 1/26/2021.

Right at the 15 min mark there were squeezing in the abdomen, chest and neck area My heart rate was over 150 Heart rate slowed down then I started having Palpitations I started to feel shaky, My hands and feet felt like Pins and needles Doctors checked my Blood pressure and it was elevated everything last 3 hours

Had rash, felt like she was having hot flashes and passed out on her dialysis unit and was taken to the ED.

Immediately felt sore in arm then felt hot and sweaty in post vaccine waiting room dizzy blurred and blacked out vision... Vasovagal syncope episode Emt and nurses came right over gave me oxygen and water.....felt better after approximately 25 minutes of treatment....drank 3 bottles of water was able to walk and leave without going to hospital around 12:15pm Arm severely sore for 48 hours.

Per HCW, approximately 30 -45 minutes after receiving vaccine, she developed severe chest pain radiating to left arm, left breast. HCW reported she sought treatment at Emergency Room. Per HCW, she was evaluated for a myocardial infarction and troponins were negative. HCW reports Chest pain have subsided; however, left arm heaviness, left chest/breast area is tender to touch.

Initial ringing of bilateral ears s/p injection lasting 3 hours. Next day tempt 100.1-101 with fatigue, malaise, chills and headache. Starting 1/22 episodes of flushing, chest tightness, dull head pain and dizziness. Episodes come and go. Will often have numbness in bilateral arms during and after dizziness. No LOC at this time.

Symptoms - Arm tenderness, chills, increased heart rate (110), low grade temperature (100.2), chest heaviness; treatment Tylenol as needed

22 minutes after vaccine experienced severe racing palpitations, elevated heart rate over 150 bpm and visual changes. This lasted one hour. Had mild chest pressure and the visual changes the rest of the day.

vomiting, dizzy, severe headache, ?passed out?, currently remains tired with headache she has taken ibuprofen

22 minutes after vaccine had severe racing palpitations, a heart rate of over 150 and visual changes. Lasted one hour. Visual changes and some feelings of chest pressure lasted the rest of the day.

Within a few minutes after the vaccination in the Post Vaccine Observation area the patient reported chills, nausea, headache, itching, and "feeling like I'm dreaming". Patient also had an elevated systolic blood pressure. Diphenhydramine 25mg PO was given and the patient was transported to the emergency department via wheelchair. Patient was observed in the emergency department and discharged home.

Pt with known history of severe asthma, tolerated first vaccine well. Second shot given this am, stable after 30 min observation period. Returned ten minutes later with chest tightness and sob c/w asthma exacerbation, taken to ED

Pt with known history of severe asthma. Tolerated first vaccine well, observed for 30 mins after vaccine, doing well, returned to area 15 mins later with chest tightness and shortness of breath consistent with asthma prior - taken to ED for evaluation given history.

1/26/2021 0230 pain at the injection site, body aches, increased heart rate, fever, and extreme tactile, auditory, and visual sensitivity. Symptoms resolved 1/27/2021 at 0500.

SYNCOPAL EPISODE (FAINTED AND FELL TO FLOOR, CAUSING LIP LACERATION AND FRACTURED TEETH), RIGORS, CHILLS, TACHYCARDIA

43 y/o F w/ pmhx of asthma requiring intubation x2 (most recently in 2017) c/b PE s/p AC presents with acute onset SOB s/p 2nd dose of COVID vaccine 30 minutes PTA to ED. Pt initially presented to express care and sent to ED. Pt w/ increased work of breathing. Pt c/o chest tightness. Denies fever/chills, URI sx, cough, CP, palpitations, N/V/abd pain, urinary sx, LE swelling, numb/tingling. Denies throat closure, itchiness, rash. Pt on prednisone 30mg daily for a recent asthma exacerbation that has been improving. Denis prior allergic reactions. 43yr female pmhx previous hx of pe, asthma on chronic steroids comes in with shortness of breath s/p covid vaccine. Patient on steroids for asthma exacerbation currently. Vitals show that he is tachycardic, other vitals wnl. On exam patient talking full sentences, no accessory muscle, no wheezing, saturating 100% on room air, no rash, no stridor. ddx allergic reaction, less likely asthma exacerbation vs anxiety, less likely pe. Plan for benadryl, steroids, pepcid, labs, chest xray, covid-19, reassess.

Morning of vaccine sneezing by late afternoon tired headache Tuesday Headache sneezing sinus pain Wednesday fatigue headache sinus pain dizzy Thursday confirmed covid previous symptoms including chest congestions

Headache, chills, generalized muscle aches, arm pain, fatigue, nausea, stomach pain, congestion, rapid heart rate and breathing.

She received her first dose of Moderna COVID-19 vaccine at 7:30 AM on 1-22-21. At 9:15 AM, she felt lightheaded, her heart was racing, and vertigo. She had a nurse check her blood pressure and it was 101/65 and her heart rate was 138 bpm. She felt presyncopal so she went to the ED for evaluation. By the time she got to the ED, she felt her throat was scratchy, and when she would lie down flat she felt her throat was occluding. She notes that she is s/p tonsillectomy in 12-2020, and considered whether that was playing a role in her symptoms, but she had not had any of those throat symptoms for 1 week prior to getting her COVID-19 vaccine. In the ED, she was given IV medications and IV fluids. ENT was consulted. Her symptoms got better with medications, she is still experiencing some throat dryness but otherwise is feeling back to her usual self. She never had any rash, flushing, itching. She had a little tenderness at the injection site only. She never had any difficulty breathing, lip/eye/tongue swelling, wheezing, coughing, shortness of breath, vomiting/diarrhea/abdominal pain. She did have nausea when she felt vertigo.

Employee states she had low grade temp after the vaccine. The day after vaccination (1/27/21) her heart rate was between 140-150 and she described feeling she was short of breath. She was seen at an urgent care where an EKG was done and she was given 1 Liter of fluid. Employee feels better today and is resting at home. She says her HR was around 110 while resting in bed at home. She states she no longer has a fever.

A few minutes after receiving the vaccine I began to feel light headed, dizzy and my heart rate was climbing. I wear an Apple Watch and notice my heart rate was steadily climbing. I asked the exit secretaries to be seen by a nurse and as they were getting a nurse my heart rate reached 169 and I was feeling faint and beginning to shake. When the nurse came she noticed how white my hands were and my breathing was becoming labored. The nurse called a code white and an ICU nurse and respiratory specialist arrived to assess me. I thought I would pass out and they had me lay on my back with legs up. They tested my blood sugar and were assessing my vitals. My breathing was fast but I was still able to breathe. My heart rate started to slow down but remained somewhat high. they helped me into a wheelchair and escorted me to the emergency department. I was assessed for cardiac concerns and labs were taken. After a couple of hours in the ED the dizziness started to subside but I had excessive thirst and dry mouth and slightly swollen tongue. I had feeling of butterflies in my stomach off an on. My heart rate stabilized and I was cleared to go home after four hours.

After three days of malaise, fatigue, fever, nausea, elevated heart rate, and arm soreness, symptoms subsided. Then a pale red maculopapular rash erupted around site of injection, growing from an inch in diameter to three inches over three days. Itching is also occurring at irregular intervals. on 1/24/21 there were diffuse hives around injection site and upper arm. These have disappeared but itching still occurs irregularly and intensely. The rash subsided after 4-5 days.

1/25/21 received vaccine; mins after paramedics called pt was experiencing blackout, blood pressure high, high heart rate, heart flip flops, weak, tingling hands/feet, difficulty breathing, cough to be able to breath, chest pains, splotchy skin areas, brain fog, hot/cold, happens every morning since besides 1/28/21 takes two hours to shake, symptoms returned 1/29/21 morning.

During the 15 minute observation following the 1st Moderna vaccine dose, the patient reported her tongue 'felt thick,' flushed skin, redness on face, neck, hands, BP=98/60, HR=100. Patient felt 'jittery' and 'heart racing.' Was transferred to ED for evaluation given that patient reported her tongue 'getting tighter.' In the ED, the patient was treated with diphenhydramine 25mg x 2 doses, methylprednisolone 125mg x 1 dose, famotidine 20mg x 1 dose, and NS IV fluids. Hypoglycemia was ruled out with CBG=87. The physician avoided treatment with epinephrine due to it being listed on her allergy list with a reaction of 'shortness of breath.' Symptoms resolved over the next 3 hours. The patient was discharged home with a new prescription of oral prednisone taper. Subsequent follow-up with her primary care provider, in consultation with an ID provider, recommended that this patient NOT get a 2nd dose. Covid-19 vaccine was added to her allergy list with a reaction of 'anaphylaxis.'

Rash, lymph node on neck over clavicle swollen severe pain 4 days so far, chills 4 days, severe headaches, stomach ache, nausea, loss of appetite. Extreme tired ness, excessive sweat when cold, lethargic, some mild heavy chest and back pain when taking deep breath not constant.

20 minutes after shot numbness and tingly in left side of face only lasting about an hour. 1/29 @ 8:00 pm soreness at injection site continuing still (49+ hours). 1/29 @ 11:00 pm shaking and chills lasting all night with sweating, severe myalgias, fatigue, headache and fever (100.6). On 1/29, before going to bed, 1 took Benadryl with no relief. Confined to bed for 24 continuous hours (1/30). On 1/30 I took Tylenol with minimal relief. Tightness of chest on 1/31. Headache continues currently (1/31), chills, fever and sweating resolved.

Palpitations Fast heart rate Fatigue Moderate body aches Moderate chills Headache Nausea Sob- may be anxiety related

patient with complaint of feeling tightness in jaw and throat, nausea, dizziness, and heart palpitations immediately following the vaccine. resolved after 30 minutes of observation.

After 4 days of my first dose of moderna vaccine i felt tightening on my throat. I took benadryl, after like 15mins i started to feel relieved. That?s why I?m not taking the second dose. And the. 14 days later after that first dose i woke up in the middle of the night feeling like my chest gonna pop out, i counted my pulae they were normal but i was so weak to even get up and get water on the table which was 6 steps from where i sleep.

Dose 1: Light headed, asthmatic light breathing after 10 mins. mild headache within 1 hour. Extreme Headache lasted 4 days intensified after first full day, arm tenderness 5 days Dose 2: Light headed, extreme nausea, heat flush, redness in face within 5-15 mins of shot. Continuous nausea, no appetite for 18 hours; first evening sever fatigue full body aches, low mobility in legs, serve chills and extreme headache; second day nausea improved, fatigue, body aches, chest tightening, intermittent headache - treated with Advil. Evening fatigue, chest tightening, chills

Fever of 106, extreme swelling of arm at injection site, tinnitis, shortness of breath, tachycardia, headache.

Moderna COVID-19 Vaccine EUA: Vaccine recipient reported that approximately 15 minutes after receiving the vaccine she became hot, tachycardic, and felt that she was going to pass out. She stayed for an additional 15 minutes for monitoring. She reported to have developed numbness and tingling in her face. She was sent to the ED for possible allergic reaction. She was administered diphenhydramine and prednisone. Upon reevaluation her symptoms resolved and was discharged to home.

Palpatations, increased heart rate (double normal resting heart rate), elevated blood pressure, dizziness, shaky, throat became increasingly sore, voice hoarse. Treated with 50 mg benedryl and saline IV drip after sitting in the ER waiting room for an hour+ Heart rate returned to 80-90 beats per within 90 minutes, dizziness subsided, throat returned to normal

At or around 2:00 am I became very restless, got out of bed and walked into the bathroom. I became nauseous, had a slight headache, dizzy, a cold sweat and began having intense stomach cramps. Within 1 minute I passed out in my bathroom and was found face down in my bathroom. It was clear that I hit my head and lost a tooth. I was taken via ambulance to a local hospital.

Seconds after the injection I had severe dizziness and was sore on the vaccine sight. Within 12 hrs of that I experienced stomach flu-like symptoms, next it was body aches and difficulties breathing. My chest began hurting by my heart. My symptoms worsened by the hour

9 hr post vaccine: mild congestion, fatigue, low grade fever 13 hr post vaccine: shaking chills, 102 F fever, severe nausea, piercing headache, fatigue---severe symptoms persisted for 17 hours, then lessened, increased resting heart rate 20 hr post vaccine residual nausea and fatigue

2/5/2021 extreme exhaustion, dizziness, weakness, extreme sweat lightheaded passed out at work, fever, body aches, red irritated swollen extreme pain at injection site. 2/6/2021 fatigue, dizziness, weakness, muscle joint pain slight fever, red irritated swollen pain tingling arm electric shock like pain sporadically at injection site.

Fever to 102.5, chills, sweating, tachycardia, muscle aches, fatigue which started 16 hours following vaccine. These lasted about 12 hours, then resolved. Of note, I had mild COVID, 8 weeks prior to vaccine.

11 hours after vaccine, fever to 102.8, chills, tachycardia, mild headache, body aches and fatigue. Low grade temps, body ache and fatigue lasted approximately 18 hours.

I received the second vaccine on 1/27/2021, at 255pm. Around 730pm that night I started to feel very lethargic. My normal temperature is usually around 95-97 degrees. When I woke up at 430am, my temperature was 99, the lethargy was much worse, I had the chills. I called into work, and then went back to bed until around 10am, when I woke, and was drinking coffee, i suddenly started having visual hallucinations (only had this once with a on old antidepressant as a teenager). I took my temp and it was 100degrees. By 130pm, my temperature was 103 degrees, with severe chills, lethargy. I slept 20 hours total that day. I eventually took 1000mg of Tylenol sometime the evening of 1/28/2021. I was very ill the entire night, but welt 98 % better on 1/29/2021. Following the first vaccine, on 12/29/2021 at 605pm, I was very tired for 7 days. The 5th day after the vaccine, i had coughing, chest heaviness, sinus congestion fairly significantly. I felt like I was on the verge of becoming ill. The Tuesday following the vaccine, I got a COVID19 test out of concern, but it was negative. Eight days after the vaccine, I had a sudden severe migraine at 930 am the caused immediate double vision and extreme pain.

Fever with in 24 hours of 103.7, severe body aches arthralgia, headache, dizziness, chest pain, lymphadenopathy, injection site pain. Fever ended after 24 hours but remained with bone pain in long bones and chest pains and severe lymphadenopathy. Took Motrin and Tylenol for discomfort. After 6 days and still having chest pain went to Emergency room for eval. +D-dimer and chest cat scan done. No pulmonary embolus. Negative troponin, chest pain unresolved but not really any explanation given.

Approximately 12 hours after the vaccine felt nauseated, and then she passed out. She got really cold to the point that she was layered up with blankets, shivering with 4 layers, teeth shattering, possibly going into shock, took Tylenol, her temp was 100. She went to sleep and was just trying to get warm. The next morning she still had a fever of 100. She continued to take Tylenol and by Friday 2/5/21 was okay. She is 4'11 and weighs 85#, wondering if the dose was too strong for her body frame, otherwise healthy person.

Vaccinated 2/4/21. On 2/5/21 in the AM, she developed a dull headache, sore throat and injection site pain/swelling. She felt that the pain went into the lymph nodes and into her back. The headache, pain and sore throat worsened over the afternoon. By the time she got home at 4:30pm she had whole body aches and was feeling really bad. She developed facial and eyelid swelling. She applied ice. Her eyelids swelled so much that they cracked. Her face has a dry, red rash. She later got up to take bedtime medications and she passed out. She began vomiting. She declined an offer to call the ambulance or to go be seen by a doctor. She took tylenol for pain and zofran for vomiting. On 2/6/21, she developed diarrhea. She was

Primarily pruritic rash. Started on the left arm near injection site. Exacerbated by day of onset of rash after spending time in a hot tub. Urticaria rash present prior to exposure to warm water. Urticaria at first even though 4 days after vaccination. Then started on right arm. Later spread to trunk, upper legs (anterior & posteriorly), then neck, scalp line (face spared, as were palms and soles of feet). Rash was distinct maculopapules, no pustules, no vesicles, no petechiae; + blanching. No other systemic symptoms, no other physical exam findings, + dermatographia. Started on medrol dose pack on 1/30/2021. Seen in ED on 2/1/2021 and hospitalized until 2/6. Seen in ED again 2/7/2021. Treatment History: 2/1 - 2/6/2021 Ceftriaxone 1 gm IVP on 2/1 Famotidine 20 mg IVP Q12 hrs Benadryl 50 mg IVP Q6 hrs prn Hydroxyzine oral prn Ativan oral prn Methylprednisolone 40 mg Q6 hrs x 4 doses, then 40 mg Q12 hrs x 3 days Discharged pn Prednisone 40 mg BID x 4 days, 30 mg BID x 4 days, 20 mg BID x 4 days, 10 mg BID x 4 days, 10 mg daily x 4 days Also given betamethasone dipropionate augmented 0.05% topically BID prn 2/7 Changed to zyrtec from hydroxyzine

At 11:29 a female patient asked for my assistance.Patient complained of dizziness when putting her head back. Also stated she had some numbness and tingling in her arms and hands. Patient was pale. Patient was unsure if her symptoms were related to the vaccine or if they could be related to her MS. The patient was walked with me to a private area where we sat her down and took her BP (106/54), pulse (88) and Oxygen sat (100). We monitored said patient for 30 minutes. We provided her with warm blankets, water and asked her to eat a snack that she had with her. Vitals were monitored numerous times over the course of the 30 minutes with all vitals remaining in the same general range. Her temperature was 98.4. Over the course of the 30 minutes patient's cheeks became rosy and improved in color. Patient began to move about more, scanning her phone and engaging more freely in conversation. At the end of 30 minutes we took her BP sitting and standing and there was no significant difference. At this point the patient felt comfortable leaving our area. We offered continued assistance if she felt she needed it. Patient declined. Patient was encouraged to go home and rest and have someone available to monitor her for the rest of the day. Patient stated her son lived down the street and she would have him come over to her house. Patient stated she felt like she does after a long stressful day at work. Patient stated that her MS often causes her to feel like this when she exercises or works a long day at work. Patient discharged home ambulatory to her home and care of her son.

Within 5 minutes of getting the injection this morning, she simultaneously turned red and vomited. Her BP was up, she was upset, and shortly thereafter turned red again and felt as if her heart was racing. At your site she was administered Zofran and Benadryl and out of an abundance of caution she was sent for evaluation to the ER. She was evaluated, exam was normal, she recovered easily, and actually returned to work and was sent home to rest.

I experienced heavy menstrual bleeding, nose bleeds. This lasted for 24-48 hours. It had completely gone away on 02-05-2021.

I was feeing bad with left leg pain, and arm soar. Later around 11:00 PM I started having shaking chills, more soar arm, and fever, with low blood pressure . My PCP recommended me to take acetaminophen and keep hydrated. Symptoms keep until next day 8:00PM.

Triggered adrenal crisis/event (identical to same I usually experience every 3-4 months) Hot flashes, tremors, headache, nausea/vomiting, diarrhea, erratic heart rate, passing out. Lasted approx 3 days

In the morning of 2/11/21 received very bad headache, then once at work, shakes, trembling all over my body, sever pain behind right eye, upset stomach, cold/hot spells, heavy weight on my chest (breathing light and fast), dizzyness. 2/12/21 - upset stomach, headache, fatigue

Patient was dizzy, lightheaded, warm all over, and had chest pain. EMS was called. BP was 100/60, HR 136, RR 25, temp increased to 99.5 F. She was observed for 15-20 minutes by EMS. She then left on her own and was not taken by the EMS.

couldn't move her face and all the left side of her body/ Drooping Face/ Bell's Palsy; couldn't move her face and all the left side of her body; palm went numb; hip pain; lower leg pain; heart racing; really low blood pressure; arm was itching, her whole body was itching; Tongue and roof of the mouth numb; really bad headache; rash on both arms; nausea; vomiting; freezing; chills; Severe allergic reaction/Allergic symptoms; diarrhea; low grade fever; A spontaneous report was received from a healthcare professional who is a 43-year-old, female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and couldn't move her face and all the left side of her body, her palm went numb, headache, body aches, chills, had a low-grade fever, diarrhea, arm pain, arm itched, whole body itching, rash on both arms, nausea, really bad headache, vomiting, freezing, low blood pressure, hip pain and lower leg pain and a bad headache. The patient's medical history included helicobacter pylori, two cervical spinal fusions, allergies to shellfish, strawberry leaves and dust. No concomitant product use was reported. On 26 Dec 2020, the patient received their first of two planned doses of mRNA-1273 (Lot number: 039K20-A) in the left arm intramuscularly for prophylaxis of COVID-19 infection. On 23 Jan 2021, the patient received their second of two planned doses of mRNA-1273 (Lot number: 013L20A) in the right arm intramuscularly for prophylaxis of COVID-19 infection. On 26 Dec 2020, approximately 20 minutes after receiving the Moderna COVID-19 vaccine, the patient reported she experienced a headache, body aches, chills, had a low-grade fever, diarrhea and arm pain. The headache and arm pain resolved after 4 days. On 23 Jan 2021, after the patient received her second dose of the Moderna COVID-19 vaccine, she reported her arm itched, then had whole body itched, a rash on both arms, was nauseated with a bad headache and vomiting. She stated she went to the emergency care unit and was given diphenhydramine 50 milligrams intramuscularly, a steroid injection and intravenous fluids. She stated, her legs and arms were shaking, she was freezing, and her teeth were chattering. Everything disappeared 2 hours later. The patient stated she went home but continued to vomit, had fevers, headaches, chills and body aches for two more days. On 30 Jan 2021, the patient reported she had a rash, was nauseated and her heart was racing. She road in an ambulance to the emergency room. She stated her palm went numb, she could not mover her face or the left side of her body. She stated, "they thought I was having a stroke". She also reported her blood pressure was low. The patient reported, they gave her Tissue Plasminogen Activator (TPA) and diphenhydramine. She reported she was able to mover her arm a little better. On unknown date, the patient reported that she was in the Coronary Care Unit (CCU) on bed rest with monitors. The patient reported she had hip pain and lower leg pain that was making her limp and a bad headache. On unknown date, the patient reported she had a magnetic resonance imaging (MRI) and computed tomography scan (CT) and stated, "it only showed a narrow spine". The patient stated she had a spinal fusion (date not provided). Treatment for the event included diphenhydramine, a steroid injection, intravenous fluids, and Tissue Plasminogen Activator (TPA). Action taken with mRNA-1273 in response to the events was not provided. The outcome of the events, headache and arm pain, were considered resolved on 30 Dec 2020. The outcome of the events, arm itched, whole body itching, freezing, rash on both arms, were considered resolved on 23 Jan 2021. The outcome of the events, couldn't move her face and all the left side of her body, her palm went numb, headache, body aches, chills, had a low-grade fever, diarrhea, rash, nausea, really bad headache, vomiting, low blood pressure, hip pain and lower leg pain, were considered unknown.; Reporter's Comments: This case concerns a 43-year old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and couldn't move her face and all the left side of her body, her palm went numb, headache, body aches, chills, had a low-grade fever, diarrhea, arm pain, arm itched, whole body itching, rash on both arms, nausea, really bad headache, vomiting, freezing, low blood pressure, hip pain and lower leg pain and a bad headache.Very limited information regarding these events has been provided at this time. Further information has been requested.

body aches, hot and cold spells, chest tightness, nausea, headache, chills, sore throat started 8 pm day of vaccine. Lasted 3 days

Right arm became very painful and unable to move due to the stiffness of the upper arm. Could NOT use or lift arm at all for 24 hours. At 10:30pm on the 13th, my husband and I decided to try and move my arm slowly up and down to help "loosen the stiffness" when my husband lifted my right arm to about shoulder height, the pain was so bad I fainted. I have never fainted before in my life. I was out for about 2-3 minutes.

Violent side efdects after injection: 103 degree fever, vomiting, diarrhea, headache, dizziness, low blood pressure, weakness, chills, muscle pain, joint pain, nausea, fatigue.

I got the Vaccine at about 1:45 PM. About ten min later my heart started racing and it was getting harder to breathe. We called over someone in the waiting lot and they accessed me and gave me benadryl. After another 5-10 min I couldn't get a good breathe, hard time swallowing, couch and itch in throat and got an epi-pen and transported to ER. I was put on steroids and beta blocker and stopped the reaction. While in the ER my O2 went down to 92 but I was better than before. I went home after hours of observation with prednisone and Beta blockers. I followed up with my Dr. When the 5 day steroid was stopped I almost immediately started struggling to breathe again and hard time swallowing. Dr. put me on a longer dose of prednisone. I'm starting to taper off the prednisone and my throat is hurting, itching and a little swell. I follow up again today.

The patient received her vaccine but after few minutes she said that she is feeling dizzy. Blood pressure checked and it was 140 over 110. We kept monitoring the patient for 15 more minutes but she said I am feeling okay after that. At 3:20 PM, we called her and she said she left early from her job to home and she is feeling fine now.

Patient presents for evaluation of encounter for immunization. Here for moderna COVID-19 vaccine #1. See scanned vaccination screening form and post vaccine questionnaire.@1713 Patient reports that her lungs "felt tight". She denies mouth swelling, facial swelling, tongue swelling, throat tightness, difficulty breathing or speaking. Denies GI distress, nausea. Denies rashes, itching or other symptoms. She denies allergies. Denies chronic conditions. Denies daily medications. She reports her only medical history is "childhood asthma" and does not take any medication currently. (1715) Patient escorted to exam room for privacy and monitoring. Patient able to ambulate without difficulty or distress. She reports her "chest tightness" is a 6 (0-10 scale). And denies other symptoms including chest pain, itching, mouth swelling, SOB. Patient reports she prefers to sit in chair, vs lying on exam table, VS monitored by RN. ROS: CONSTITUTIONAL: Negative for chills, fatigue, fever, and weight change. EYES: Negative for blurred vision, eye pain, and photophobia. E/N/T: Positive for Denies mouth, tongue swelling. Denies throat tightness.. CARDIOVASCULAR: Negative for chest pain, palpitations, tachycardia, orthopnea, and edema. RESPIRATORY: Positive for Denies cough, distress, endorses "tight chest". GASTROINTESTINAL: Positive for Denies nausea, vomiting, GI distress, diarrhea. INTEGUMENTARY/BREAST: Positive for Denies rashes, lesions, changes to skin.. Vitals: Current: 2/19/2021 4:48:38 PM T: 97.9 F (temporal); BP: 174/104 mm Hg (right arm, sitting); P: 81 bpm (finger clip, sitting)O2 Sat: 100 % (room air) Repeat: 5:38:26 PM BP: 182/108mm Hg (left arm, sitting, 5:17pm) 5:38:59 PM BP: 158/97mm Hg (right arm, sitting, 5:26PM) 5:40:22 PM O2 Sat: 100% (room air, 5:26PM) 5:39:56 PM P: 73bpm (finger clip, sitting, 5:26PM) Exams: Initial Exam completed by NP at 1713, 1720, 1730, 1740 and 1746. No changes from baseline GENERAL: well developed, well nourished, in no apparent distress;; well developed; well nourished; well groomed; no apparent distress EYES: lids and conjunctiva are normal; pupils and irises are normal; E/N/T: normal external ears and nose;; Hearing: grossly normal Lips, Teeth and Gums: normal; Oropharynx: normal mucosa; NECK: Neck is supple with full range of motion; RESPIRATORY: normal respiratory rate and pattern with no distress; even and unlabored, no wheezing; CARDIOVASCULAR: normal PMI placement; no thrills, heaves, or lifts; normal rate and rhythm without murmurs; normal S1 and S2 heart sounds with no S3, S4, rubs, or clicks;; normal rate; regular rhythm; irregular rhythm; Radial pulses +2 CR< 3 seconds BUE; GASTROINTESTINAL: no masses or tenderness; SKIN: no ulcerations, lesions or rashes no skin thickening, induration, or subcutaneous nodules; NEUROLOGIC: AOx3, awake, alert, calm PSYCHIATRIC: mental status: alert and oriented x 3; appropriate affect and demeanor; recent and remote memory are intact; good insight and judgement; Procedures: Encounter for immunizationBenadryl 50 mg tab given PO per, NP at 5:14pm 1. Epinephrine given IM, in the right thigh; administered by: employee; ( lot #0GM147; exp. 11/2021 ) 5:37pmVS were monitored closely by RN and NP during reaction, see chart for RN's VS **Requested RN to chart her VS: see "Post COVID-19 Vaccination Questionnare for VS completed by employees 1714 Benadryl given PO 1726: VS: Ox 100% on RA RR 16 HR 73 BP 158/97 1731 VS: Ox 98% RA RR 16 HR 84 - patient reports chest tightness is worsening: Ordered IM epi, given by RN 1738 VS:Ox 99% RA RR 16 HR 83 BP 167/114 1742 VS: Ox 100% RA RR 16 HR 89 1746 VS: Ox 100% RA RR 16 HR 80 167/98 Plan: Encounter for immunizationvaccine given per protocol.30 minutes after vaccine, patient c/o chest tightness. PO benadryl and IM epi given per protocol, VS monitored per protocol and documented by RN and NP 1) Protocol followed for anaphylaxis 2) Patient remained stable under care. Patient AOx3, awake, no respiratory distress, talking and smiling. 3) (1537) Informed patient we are calling 911 due to administration of Epi and patient's reported symptoms. Patient refused. Re-educated to the importance of calling 911. Patient refused x 3. 4) Husband presented to drive patient to the emergency room. Re-educated to the importance of calling 911 for anaphylaxis. Patient and husband refused. Husband committed to taking patient straight to Emergency Room, and to call 911 on the way if she gets worse in any way. Patient and husband both agreed to this. 5) Educated patient that she must seem emergent medical attention for anaphylaxis. Educated patient to NOT get second vaccine. 6) (1746) Patient reports her chest tightness has gone from a 6 to a 2 (0-10 scale) 7) Patient and husband v/o and agrees to POC. 8) (1746) Patient left in stable condition, under the care and supervision of husband with plan to go straight to the Emergency Room and to call 911 immediately if anything changes or worsens. 9) Case and chart reported to Medical Director.

Patient started to complain of chest tightness and coughing at 1545, was hot with mask on, used her albuterol rescue inhaler because thought it was asthma acting up. No relief after 2-3 minutes, Doctor notified to evaluate. Epinephrine recommended, EMS called. Epinephrine administered at 1558. Respiratory relief with epinephrine, patient started itching chest, back and arms. EMS arrived at 1620.

Symptoms of anxiety, hand and face skin tingling, and mild SOB began at 2:50 PM. Patient stated she had a history of anxiety. BP 132/94, Pulse 124, O2: 98% (measured with finger pulse oximeter). At 3:12 symptoms progressed to blue lips, cramping of hands, complaint of "weight on the chest", EMS was called. Pulse was 112, O2 was 98%. No rashes, swelling, or nausea noted. Had patient lie down on a yoga mat and helped her with anxiety reduction strategies, gave her sips of water. Transferred to EMS at 3:26 PM. Patient was evaluated, recovered, and released on-site.

My shot was on Sunday, at midnight that night the headache began. Monday, called into work. Monday I had a horrible headache, arm swelled to about a golf ball size at shot site. My whole left shoulder to almost mid back was in pain all day. Tylenol and ibuprofen did not touch back/shoulder pain or headache . I was very tired. Tuesday same thing horrible headache and arm soreness, yet not as bad for back pain. Didn?t go to work. Wednesday tried to go to work but had diarrhea horribly and a headache, ended up leaving only a few hours of being there. Thursday , called in sick again with a horrible headache. Called family physician to be checked. 3 and 1/2 days off work. Dr. Decided to treat it as a migraine, prescribed me medicine and headache has been gone since. It is late Thursday night, 25th. Also my blood pressure was high when I went in, usually 120/80 and today it was 144 or 140 over 80

Felt like a panic attack. Short of breath, heart racing, tunnel vision, dizzy tingling face/lip. Worst of it lasted about 2-3 hours. Very fatigued afterward.

Weird Taste in my mouth within 2 minutes and Accelerated heart rate. From the time of injection until current, chills, intermittent low grade fever, headache and body aches different from my normal aches. Worse GI issues, memory issues worse than normal, feeling of disorientation at times, little difficulty catching my breath (only used rescue inhaler once). I felt a bit better about a week and a half post injection. But, then, started to feel worse, including vaccinated arm feeling heavy and sore again - February 27, 2021 - noticed reddish/ pink abnormal circle around injection site this is new, delayed, overall worse malaise, I felt a general feeling of yuck. I know it?s not a great descriptor, but, it kind of fits. Basically, lupusy, but worse.

developed fever and chills within 24 hours of vaccine and at 4 weeks out had unprovoked acute DVT in the axillary and subclavian vein on the side of the vaccine.

after injection, pain at site, 4 hrs later, headache, 4 hrs after headache, arthralgia, 4 hrs after arthralgia, chills. In the morning at 0600, woke up with nausea and BM urgency. Shortly after N/V, chest pain and delerium start. Chest pain caused anxiety. No SOB. Upon standing, I blacked out and fell to ground. When I came to ( 5-10 minutes later ) nausea disappeared but arthralgia and chills still present. I did not take any OTC/ pain relief meds at all since I did not want to blunt my body's immune response. Nausea does not return and the CP/ hypotensive/shock episode made me stick to sitting on the couch for the remainder of the day. I took 400mg IBU around 8 am and all SX disappear by 1800.

I received my 1st dose 1/12/21. I experienced 3 black out spells afterwards. Approx 20 min after shot. Immediately after shot my body got hot and my feet were on fire. On the way home approx 1 1/2 hours afterward my mind was foggy. 2 hours after shot I experienced tachycardia with heart rate at 138 beats per min and blood pressure 138/94 A friend came over to stay with me cause all I could do is lay down. My legs felt like they weight a ton 3 hours after shot. I had chills and nausea that lasted 48 hours after 1 shot. I am required by my job to get 2nd dose next week. Do you recommend 2nd dose due to reaction off 1st shot?

Symptoms began at 14:50. Tingling and shortness of breath progressed to dizziness and hand cramping, bilaterally. BP 132/94; O2 saturation: 98%, blue lips, anxiety. Had patient lay down, monitored VS x 5, called EMS at 15:12pm. Transferred to EMS at 15: 26pm. No rashes, swelling on nausea. Patient assessed by EMS and declined transfer to hospital.

Patient was watched for 1 hour after receiving the 2nd vaccine due to face and neck tingling, chest pressure and racing heart. On the second day follow up to patient, all symptoms had resolved.

experienced jitteriness and rapid heartbeat. We kept her seated, monitored her and gave her water to drink. Monitored for 30 minutes. We offered to call 911 and she declined, saying she did not feel that bad. We monitored with someone with her one on one for 30 minutes. She was fine and cheerful when she left the pharmacy.

2am woke up with severe chills and a severe migraine. At 10am severe migraine progressed to skin on scalp feeling like it was pulled too tight. From there I began to feel an internal tremor in my head, almost like if you ran a jack hammer all day and then stopped, that shaky, off-kilter feeling. I used the bathroom that morning and had massive diarrhea, experience a vaso/syncope episode and passed out. All week I felt like this and experienced nausea, dizziness, heart palpitations, severe migraine, internal tremor, severe anxiety and severe thirst. By Friday, 2/26/21, it got so bad and my blood pressure dropped to 112/50, that I was taken via ambulance to the ER. They gave me IV fluids, ran labs, EKG, etc. Blood pressure went up to 137/91. Released to rehab at home. 2nd ER visit to Hospital on Sunday where they repeated labs, EKG, gave me fluids and treated symptoms. Both trips I was labeled Tachy.

5-15 minutes after injection: Tasting metallic Difficulty swallowing Throat tightness Chest tightness Coughing Red chest 27 hours later: Flushed and warm to touch face and chest

This was my 1st dose. Within 3-5 minutes after the injection, I felt nausea; difficulty swallowing; swelling in the back of my throat; heart beating faster; body shaking. The swelling in my throat interfered with swallowing but did not affect my breathing. It wasn't big enough to close airways.

Flushing, palpitations, urticaria on chest, near syncope, chest tightness, BP 170/100 Pulse 130 Resp 18. 1:50 pm 50mg Benedryl po. Pt then felt worse. Transported to ER.

Chest pain & rapid palpitations, shortness of breath , headache , swollen at the left side of my armpit & pain in sore in the area of administration

All the severe complications such as Fever, shortness of breath, headache, body ache, chest pains, heart palpitations.

Started coughing at 2:15pm and unable to stop, became blushed with chest tightness, throat was scratchy. VS taken and stable, MERT was call and was sent to ER. IV started and Solumedrol, benedryl, and pepsid administered. After 15-20 minutes coughing stopped.

On day 8 I got Covid Arm at the injection site. Lasted for 3 days. On 3/721 6:30am I woke up for work and had terrible chest pain. It knocked me back a few steps. Examined my chest and only experienced the pain when I moved a certain way. Thought I had pulled a muscle. Went to work feeling exhausted and my eyes burned. Came home early from work and passed out. Noticed that when I lay down my hands swell. Next morning I work up fine. No pulled muscle. No pain. Never experienced anything like it. I started my monthly cycle that morning. It is over a week early.

At 3:20 Client report pain in Left Forearm to nurse Client reports throbbing pain in Left Forearm Client states her arm feels like ?it?s going to explode? Client reports that she felt dizziness, pain in her chest, and pain in her back immediately after the injection around 2:30 Client was with her employer and did not want to draw attention to herself by saying anything to observation attendants or nurses She stayed past her time of approx. 2:40 because she did not feel safe to drive Client states she is no longer having chest pain or dizziness At 3:22 EMT present Vitals taken electronically: BP 137/102, Pulse 80 Client reports that she only has pain in her left forearm No swelling noted Client no longer having any previously experienced sensations such as chest pain, pain in her back, or dizziness At 3:30 Vitals taken: O Sat 99, Manual BP 110/ 90, Pulse 78 Client reports that her arm feels a lot better Client states she feels well enough to drive home Client able to ambulate to her car unassisted

Pt reported diffuse hives and hoarse voice approx. 10 minutes after injection. Pt also reported rapid heart rate and difficulty breathing. Pt appeared to wax and wane symptomatic to asymptomatic over about 15 minutes. At 15 minutes EMS was called to further assess and transport to ER. Total time from onset to EMS transport was approx. 30 minutes.

Increase in Anxiety, up and down mood swings?- increased crying and tight chest due to the anxiety, anxiety still high, going to make appt with doctor

Approximately 4 hours after receiving the vaccine I fell asleep with no recollection of the evenings events when I awoke the next day. Twenty-two hours later I developed a headache at the base of my skull/top of neck. The headache lasted for six days. I avoided taking medication until the sixth day. On day four following the vaccine the headache was severe enough to cause nausea & vomiting and I was unable to work that day. The prior day, I again experienced a complete loss of memory from the previous evening. I do not have any medical history of migraine headaches. I would manage the pain by lying down until it would subside, however, within an hour of resuming normal activity, the headache would return. I also experienced heart palpitations on day five.

within 13-14 minutes had my arm feel strange all the way to my finger tips. Then I started having fast heartbeat , heart pounding outside of chest. Also couldn't catch my breath. As of 6 hours later I still don't feel well

Right after I received the shot, my heart started to beat very fast. Since I'm a person who has anxiety, I thought maybe I was having anxiety, and didn't say anything. My heart rate eventually felt normal and I went home. However, I woke up in the middle of the night last night feeling a fast heartbeat. Today reading the information I received about the vaccine, I saw that "fast heartbeat" is listed as a possible reaction to the vaccine, so I'm reporting it.

24 hrs later, Severe headache, dizziness, muscle and joint pain in neck, hips and legs. Loss of appetite. intermittent fast heart rate. I took 3 ibuprofen at 11:30 am with no relief. I napped for two hours 12:30-2:30 with no relief. I took 2 acetaminophen at 3:00 with no relief. I could not function normally. I took 4 ibuprofen at 6pm with some relief. The next day 48 hrs later I still felt a mild headache and mild muscle and body aches. I was able to function. mild popup headaches on day 3 & 4. Better with 3 ibuprofen.

Day 1: woke up to my heart racing, lethargy later in the day along with startling to sounds, seeing things not there in periphery, felt sunburned in armpits, bend of legs & front of shins, rash in armpit that came & went, hot spots on skin in various areas, felt I was burning up from the inside out, waves of nausea. Day 12: random itching on throat, chest & arms(started slight on day 10 increased til day 12 then went away), felt sunburned all over, rash on chest that went away in approx 10 min, shoulder & wrist aches

about 1 hour after vaccine-weakness "couldn't stand up"-dizzy/nauseous, "chest felt heavy", throat felt swollen, choking on spit states she fell asleep and was "out cold" her daughter had a hard time waking her up. She states she didn't feel anything during her half hour wait at clinic and then at the end of her drive home started feeling sick and had to have her daughter help her out of the car.

9 hours after the shot I felt very nauseous. After getting out of bed, my legs felt wobbly and I passed out.

2/27/21: Covid Vaccine- immediate reaction- racing heart and pulse 150. Given oral 25 mg Benadryl. Would not come down. Called 911. Continued to rise and fall- given 25mg Benadryl via IV on transport to facility. @ facility gave 100 mg IV Benadryl and 25 mg Pepcid- sent home. Symptoms: Racing heart; feeling of doom. Overall horrible. 3/1/21: Symptoms returned- rapid heart rate. Pulse erratic on meter. Went to ER. They treated with Pepcid, Fluids and Benadryl (iv). Sent on steroid taper and Rx Pepcid. Symptoms: Pressure in chest and sharp rises and falls in pulse. Lightheaded. Raised Rash. 3/2/21: Started taper. No Benadryl. Still on Pepcid. Rash returned. Very itchy. Called neuro on call (1:30am). He said to stop steroid and take more Benadryl. Went to sleep. Symptoms: Itch across face, chest and ears. Pressure in heart area. 3/3/21: Woke up- still red and itchy. Called Neuro. She said that I am prob not allergic to steroids. I expressed my concern b/c i was so itchy the day before. She said I should just do Benadryl and if it doesn?t improve- go back to ER In 2 hours. It did not improve, so I just took steroid. Immediately heart rate accelerated. BP went to 220/100 at fire station. Light headed; red and irritable. Chest pressure. Transported to facility. Waited 3 hours- no fluids or Benadryl. Symptoms returned. THey said it seemed like ?classic panic? because there is an anxiety element from what?s been happening. THey said they don?t know what is causing it. Treated there with IV Benadryl and Pepcid. Things calmed down. Went home. Still itchy and pressure in chest. Prescribed Hydroxyzine. Flushed rash vs. raised. Feels like I went running in the cold. Treated with IV Benadryl and Pepcid and 25 mg Hydroxyzine. 3/4/21: Woke at 1:00 am hot and itchy. Took more Hydroxyzine 25 MG. Woke up at 8:00- hot and itchy. Feels like sunburn. Took more Hydroxyzine 25 MG. Appt with cardio at 11:00am. Calling for PCP. - Intermittent "attacks" in the inerim- heart rate up to 135 resting. 3/8/21Allergist appt at 2:00 on Monday. Testing for PCP Symptoms: Winded, red cheeks, flushed, feels like something is in my chest. 3/11/21: Around 12:30 started to have rapid pulse. Went to PCP at 1:30. She administered steroid injection. Heart rate jumped to 155 and remained; 911 called. Returned to ER via ambulance. Symptoms since 3/11- rapid heart rate- shortness of breath; extremely weak; left flank numbness (typical of MS flare). Facility discharged me with follow ups to endocrinology, allergy and cardiology.

The morning following vaccine I woke up with a bloody nose, which I had not experienced before. I had approximately 5-7 nosebleeds per day tues, wed, thurs and fri. I sought medical attention Friday and had blood work done which was normal. I was prescribed Oxymetazoline hydrochloride 0.05% nasal spray and have not had a nose bleed since Friday.

Swollen lymph nodes under left arm and in chest area presenting 4 days after shot and persisting for 3-4 days with pain. Severe fatigue presented 3 days after shot persisting for 4-5 days. Chest pains.

Asthma symptoms - tight chest, shallow breathing - felt better after using albuterol rescue inhaler twice

Developed severe nausea and dizziness within 10 minutes of vaccination. Later in the same day, developed severe headache, accompanied by elevated blood pressure, nausea and dizziness. Blood pressure is still high averaging 145/90 on day 4 post-vaccination. Also developed other side effects such as body aches, mild chills, and diarrhea. Blood pressure and dizziness are bothersome, however. I have an appointment scheduled with PCP tomorrow (day 5 post-vaccination).

Patient experienced a fever within 24 hours of second Moderna dose. Temperature was 103. Patient passed out and was taken the ER by ambulance on 3-16-2021. The ER kept this patient until fever subsided at about 12 midnight on 3-16-2021.

I took the vacacine Merdena.mabout one 1/2 hour in Time I started to get tightness of the chest AND palpitaciones..AND also a sensation of an electricista.

Rash down left arm, throat closure , trouble breathing, hypotension- seen by emt on side. Symptoms resolved in 1/2 hour was able to drive home

Few minutes after the vaccine had crazy fast afib, my heart was racing out of control for a few minutes, dizziness and weakness followed, next day dizzy and close to passing out several times, couldn?t drive a car, chest pressure, couldn?t get a good breath, fatigue, 48 hours later just starting to get back some strength but still feel off.

Lightheadedness,dizziness,fatigue,heart palpitations,hives immediately after the vaccine was administered. I was laid on a hospital gurney for over an hour and observed by nurses and they gave me fluids and had me do some breathing exercises to slow down my breathing&placed a cool towel on my forehead. Once I arrived at home I parked and began to walk towards my became dizzy and fell and hurt my right arm,knees&hands. I went to urgent care,my vitals were normal and I was screened for Covid and my results came back negative for Covid and influenza. The urgent care doctor ordered lab work in which I had done the next day and the results came back normal.

Short of breath Body/muscle pain Dizzy Lightheaded Loss of appetite Nausea Diarrhea All of which lasted for 4 days, flowed by 10 hours of feeling fine then unable to move without assistance.

Headache (migraine type for 10 days), double dose of Advil and Tylenol 4-5 times a day. Headache subsided after 10 days. Blood pressure dropped by 60 points (typically I have high blood pressure 140/110, it dropped to 80/60) on the first night after injection. light headed the first night.

I exp chest pain, rapid heart rate, dizziness, fatigue muscle/joint pain, brain fog lasting 2 months. I went to ER on 1/8, and have seen a Cardiologist, Allergist and Rheumatologist .I'm still exp brain fog as of today.

first day extreme tired, second day stiff neck that lasted 3 days, day 13 heaviness in chest, day 14 skin rash on site of vaccine

Diabetic patient did not administer her insulin before coming to get her COVID 2nd dose vaccine. She became lightheaded and nauseous shortly after being given the Moderna COVID vaccine. The paramedics checked her blood sugar at 493mg/dl and the patient administered her own dose of insulin (type unknown). Patient was transported to the hospital and only IV fluids were given by the paramedics.

Patient described slight warmth on her chest after vaccination. She said the sensation was similar to many months ago when she received her lidocaine/hydrocortisone shot. After 30 minute of observation, patient says feeling has dissipated. No signs & symptoms of anaphylaxis. Counselled patient about calling 911. Mentioned all the symptoms to watch out for on Moderna's EUA. I spoke to patient a week later and she said the "warmth" dissipated in about 8 hours. She said she could smell & taste the vaccine. I encouraged her to see her PCP for evaluation. She has an appointment in 1 week. She will talk about whether to receive a 2nd dose.

high blood pressure, chest pain, shortness of air - intermittent after getting the dose. Patient experienced this 2x on different occasions, the first time was 3/7/21-3/8/21 and again 3/20/21-3/22/21. EKG, stress test, and ECHO were completed after second concerning episode and no urgent cardiac issues were found. Follow-up with PCP scheduled 4/7/21.

Extreme nausea and vomiting post Covid Shot, patient became syncopal with the vomiting episodes and was admitted to the hospital

Fever, malaise , body aches, headache, foggy memory, fast heart rate lasting more then a week and progress worse each day diagnosis with sepsis in the hospital

New onset DVT/PE blood clots. Diagnosed after patient had new onset right calf pain and cramping about 9 days after receiving second Moderna COVID vaccine, came to hospital had an ultrasound which showed clot, then had CTA chest which confirmed pulmonary embolism (both done on 4/7/2021). She has no other known risk factors for thromboembolism, however a hypercoagulability work-up is also underway and will not be completed for several months.

Have had tiredness since 2nd vaccine in February and noticed shortness of breath when walking or going up stairs in mid March. Around 4/1, I started having left rib pain preventing me from sleeping on my left side and then could not breath during a massage on 4/8. On April 9th, I was diagnosed with multiple pulmonary embolisms (clots) in both lungs, reducing my lung capacity to only 30% of normal. This could be due to Loestrin birth control but I have taken hormones in the past for IVF and when younger for birth control. The reaction may be due to a combination of vaccine, Loestrin and iron but triggered by vaccine. I am currently on Eliquis to treat pulmonary embolisms.

Stable lupus with normal cell counts for years, received second dose Moderna vaccine 4/3/2021 and had 2 days of malaise however then developed increasing fatigue and weakness. Presented to outside hospital on 4/10/2021 and found to have profound thrombocytopenia, mild lymphopenia and anemia.

oropharyngeal pain; chest soreness; coughing; gagging; Gastrointestinal upset; oedema; shortness of breath; fatigue; joints hurt; nausea; headaches; pneumonia; Occasional shortness of breath at rest; Occasional palpitations; Weight increased, weight was up approximately 10 pounds; Dizziness; This spontaneous case was reported by a consumer and describes the occurrence of PNEUMONIA (pneumonia) and DYSPNOEA AT REST (Occasional shortness of breath at rest) in a 44-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Co-suspect products included non-company products TREPROSTINIL DIOLAMIN for Secondary pulmonary arterial hypertension, TREPROSTINIL DIOLAMIN (ORENITRAM) for Secondary pulmonary arterial hypertension and RIOCIGUAT (ADEMPAS) for an unknown indication. Concurrent medical conditions included Pulmonary arterial hypertension. Concomitant products included APIXABAN (ELIQUIS). On 21-May-2020, the patient started TREPROSTINIL DIOLAMIN (Oral) 4 mg every eight hours. On 21-May-2020, TREPROSTINIL DIOLAMIN (Oral) dosage was changed to 1 mg. On 19-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient started TREPROSTINIL DIOLAMIN (ORENITRAM) (Oral) at an unspecified dose On an unknown date, TREPROSTINIL DIOLAMIN (ORENITRAM) (Oral) dosage was changed to at an unspecified dose. and RIOCIGUAT (ADEMPAS) (unknown route) 1.5 mg. On 08-Feb-2021, the patient experienced PNEUMONIA (pneumonia) (seriousness criterion medically significant). In February 2021, the patient experienced DYSPNOEA AT REST (Occasional shortness of breath at rest) (seriousness criterion medically significant), WEIGHT INCREASED (Weight increased, weight was up approximately 10 pounds), DIZZINESS (Dizziness) and PALPITATIONS (Occasional palpitations). On an unknown date, the patient experienced OROPHARYNGEAL PAIN (oropharyngeal pain), CHEST PAIN (chest soreness), COUGH (coughing), RETCHING (gagging), ABDOMINAL DISCOMFORT (Gastrointestinal upset ), OEDEMA (oedema), DYSPNOEA (shortness of breath), FATIGUE (fatigue), ARTHRALGIA (joints hurt), NAUSEA (nausea) and HEADACHE (headaches). At the time of the report, PNEUMONIA (pneumonia), DYSPNOEA AT REST (Occasional shortness of breath at rest), WEIGHT INCREASED (Weight increased, weight was up approximately 10 pounds), DIZZINESS (Dizziness), ABDOMINAL DISCOMFORT (Gastrointestinal upset ), DYSPNOEA (shortness of breath) and HEADACHE (headaches) was resolving, OROPHARYNGEAL PAIN (oropharyngeal pain), CHEST PAIN (chest soreness), RETCHING (gagging), PALPITATIONS (Occasional palpitations), FATIGUE (fatigue), ARTHRALGIA (joints hurt) and NAUSEA (nausea) outcome was unknown and COUGH (coughing) and OEDEMA (oedema) had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In February 2021, Weight: 170 lb (High) Weight gain of 7 pounds. In March 2021, Weight: 164 lb High. In 2021, Weight: up approximately 10 lbs High. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. Prescribed levofloxacin antibiotic for 7 days for pneumonia. The patient did not need to use oxygen as often. Reporter did not allow further contact; Sender's Comments: This case concerns a 44-year-old female with serious unexpected events of pneumonia and dyspnea at rest, and nonserious unexpected dyspnea, chest pain, cough, oropharyngeal pain, retching, abdominal discomfort, palpitations, dizziness, edema, weight increased and expected fatigue, headache, nausea, arthralgia. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.

3/2 - Received the first round of Moderna vaccination. No immediate side-effects noted. I talked with my physician prior to getting the vaccine due to medical conditions and medications that I am taking. I was taking Xarelto due to chronic DVT/Blood clots in my left leg. After 2.5 weeks I noted my left leg was swelling and I started to have discomfort in my leg. No noticeable changes to my leg at this time that made me concerned about getting the second vaccine. 3/30 - I received my second vaccination in the morning. I ended up going into the hospital at 4 pm due to numbness and pain in my left leg. I ended up being admitted to the hospital due to a DVT behind my L knee and in my femoral/iliac veins. I was also diagnosed with May-Thurbers syndrome. All the physicians, hematologists, and surgeons were surprised that I ended up with a severe blood clot as I was on Xarelto for over two years without an incident or problem. I did not have a fall or any change in my life that would have caused this issue to happen and they were all stumped. I was switched to a heparin drip while Xarelto was clearing out of my system and in two days I had two stints put in my femoral/iliac vein on my left leg. I was changed over to Lovenox and Coumadin 5-7.5 mg before leaving the hospital. There were no concerns and I was in the hospital from 3/30 to 4/3/21. After I was discharged from the hospital I went to my primary care follow up on Tuesday 4/6/21. I was having increased pain behind my knee and overall not feeling well. I ended up having more labs completed and another ultrasound to indicate I had a small DVT behind my knee from my procedure. On Friday 4/9/21 I went in for my INR and found my coumadin was within therapeutic range. When I got home I changed into comfy clothing and noted that I had a red/purplish rash looking dots/bumps from my toes to my knees on both LE, my Left was more significant than my right. I went back into the doctor and I was prescribed a topical steroid to help decrease the edema, pain and redness. Saturday 4/10/21 - my legs became painful to the touch, they felt like they were going to burst due to pressure, and the rash/reddness was looking worse and spreading. I was sent back to the ER and was admitted back to the hospital. They diagnosed me with heparin-induced thrombocytopenia, removed me off of coumadin, and started me on Arixtra. The hematologist, physicians and staff did not know what to do and I was now deemed medically complex and had to be monitored for a few days and gave me prednisone. Once removed from coumadin the rash/pain/swelling subsided and started to diminish. I was discharged from the hospital. I returned to work on Tuesday 4/13 and after returning home I had increased pain, pressure and rash that now was visible from my knees to my hips and this was not present in the hospital. My physician is asking for a biopsy and increased my prednisone to stay at 20 mg a day. At night I have to elevate my legs or they become swollen and will become painful. 4/16/21 I wore compression tights per physician guidelines and when I came home from work I had new spots and rashes on my feet, they were swollen and had increased pain. My left ankle had a rash on it as well. After elevation and a nights rest the rash started to diminish and the rest of my legs have started to diminish or disappear.

left neck spasm; felt uneasy; slight pain under sternum; fatigue; pain in her left knee; trembling in her upper body; face became a bright red; heat in her body; weakness in arms and hands; bed bound; pain in her lower back over kidney area; her body would be drenched in sweat mostly around heart and sternum area, she could splash; injection site started having pain; her injection site started having pain, it swelled up; Had skin eruptions like a boil on her right uper buttock; the boil was thought to be cellulitis and she was given a topical antibiotic; vomiting; racing heart; facial numbness and tingling; nausea; hard time breathing; shortness of breath; hives were on her upper back and under hips; she was covered in hives from, they covered her chest in a "Vshape; cough; burning sensation in her mouth; mouth was dry, tongue was thick and full, no salivation; Disoriented; began to feel very very thirsty; drinking 1 liter of water; felt pins and needles down her arms; numbness like pins and needles on injection site and neck; and while laying in bed, she felt like she was driving a race card; could not sleep; was going to pass out; high blood pressure; "She had a spot appear on her right leg and a ultrasound of her leg was performed to verify if a blood clot had developed (clot was not diagnosed)"; twitches in her abdomen, where her abdomen would cramp up; fallen down a short flight of stairs; felt like she could not move her limbs (elbow to fingers, knees to toes),limbs felt like they were frozen and paralyzed; dizzy; vertigo; migraine, lightheadedness, ringing ears, cloudy vision and headache; felt like as if someone was sitting on her chest; had a crawling sensation; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of PRESYNCOPE (was going to pass out), CELLULITIS (Had skin eruptions like a boil on her right uper buttock; the boil was thought to be cellulitis and she was given a topical antibiotic), PERIPHERAL PARALYSIS (felt like she could not move her limbs (elbow to fingers, knees to toes),limbs felt like they were frozen and paralyzed) and DYSPNOEA (hard time breathing; shortness of breath) in a 43-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included Bradycardia and Hives (Patient recalls 20 years ago; she had hives.) in 2001. Concurrent medical conditions included Migraine. Concomitant products included RIZATRIPTAN for Migraine. On 27-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Feb-2021, the patient experienced PERIPHERAL PARALYSIS (felt like she could not move her limbs (elbow to fingers, knees to toes),limbs felt like they were frozen and paralyzed) (seriousness criterion disability), DIZZINESS (dizzy), VERTIGO (vertigo), MIGRAINE (migraine, lightheadedness, ringing ears, cloudy vision and headache) and CHEST DISCOMFORT (felt like as if someone was sitting on her chest; had a crawling sensation). On 01-Mar-2021, the patient experienced ABDOMINAL PAIN (twitches in her abdomen, where her abdomen would cramp up) and FALL (fallen down a short flight of stairs). On 02-Mar-2021, the patient experienced PRESYNCOPE (was going to pass out) (seriousness criterion medically significant), RASH MACULAR ("She had a spot appear on her right leg and a ultrasound of her leg was performed to verify if a blood clot had developed (clot was not diagnosed)"), HYPERTENSION (high blood pressure), INSOMNIA (could not sleep), PARAESTHESIA (felt pins and needles down her arms; numbness like pins and needles on injection site and neck) and RESTLESSNESS (and while laying in bed, she felt like she was driving a race card). On 03-Mar-2021, the patient experienced DISORIENTATION (Disoriented) and THIRST (began to feel very very thirsty; drinking 1 liter of water). On 04-Mar-2021, the patient experienced ORAL DISCOMFORT (burning sensation in her mouth; mouth was dry, tongue was thick and full, no salivation). On 05-Mar-2021, the patient experienced DYSPNOEA (hard time breathing; shortness of breath) (seriousness criterion medically significant), URTICARIA (hives were on her upper back and under hips; she was covered in hives from, they covered her chest in a "Vshape), COUGH (cough), HYPOAESTHESIA (facial numbness and tingling) and NAUSEA (nausea). On 07-Mar-2021, the patient experienced PALPITATIONS (racing heart). On 10-Mar-2021, the patient experienced VOMITING (vomiting). On 11-Mar-2021, the patient experienced CELLULITIS (Had skin eruptions like a boil on her right uper buttock; the boil was thought to be cellulitis and she was given a topical antibiotic) (seriousness criterion medically significant). On 12-Mar-2021, the patient experienced HYPERHIDROSIS (her body would be drenched in sweat mostly around heart and sternum area, she could splash), VACCINATION SITE PAIN (injection site started having pain) and VACCINATION SITE SWELLING (her injection site started having pain, it swelled up). On 13-Mar-2021, the patient experienced BACK PAIN (pain in her lower back over kidney area) and BEDRIDDEN (bed bound). On 15-Mar-2021, the patient experienced MUSCULAR WEAKNESS (weakness in arms and hands). On 17-Mar-2021, the patient experienced PYREXIA (heat in her body). On 21-Mar-2021, the patient experienced ERYTHEMA (face became a bright red) and TREMOR (trembling in her upper body). On 30-Mar-2021, the patient experienced FATIGUE (fatigue) and ARTHRALGIA (pain in her left knee). On 01-Apr-2021, the patient experienced CHEST PAIN (slight pain under sternum). On 02-Apr-2021, the patient experienced MUSCLE SPASMS (left neck spasm) and MALAISE (felt uneasy). At the time of the report, PRESYNCOPE (was going to pass out), CELLULITIS (Had skin eruptions like a boil on her right uper buttock; the boil was thought to be cellulitis and she was given a topical antibiotic), PERIPHERAL PARALYSIS (felt like she could not move her limbs (elbow to fingers, knees to toes),limbs felt like they were frozen and paralyzed), DYSPNOEA (hard time breathing; shortness of breath), RASH MACULAR ("She had a spot appear on her right leg and a ultrasound of her leg was performed to verify if a blood clot had developed (clot was not diagnosed)"), DIZZINESS (dizzy), VERTIGO (vertigo), MIGRAINE (migraine, lightheadedness, ringing ears, cloudy vision and headache), CHEST DISCOMFORT (felt like as if someone was sitting on her chest; had a crawling sensation), ABDOMINAL PAIN (twitches in her abdomen, where her abdomen would cramp up), FALL (fallen down a short flight of stairs), HYPERTENSION (high blood pressure), DISORIENTATION (Disoriented), ORAL DISCOMFORT (burning sensation in her mouth; mouth was dry, tongue was thick and full, no salivation), URTICARIA (hives were on her upper back and under hips; she was covered in hives from, they covered her chest in a "Vshape), COUGH (cough), HYPERHIDROSIS (her body would be drenched in sweat mostly around heart and sternum area, she could splash), BACK PAIN (pain in her lower back over kidney area), MUSCULAR WEAKNESS (weakness in arms and hands), ERYTHEMA (face became a bright red), MUSCLE SPASMS (left neck spasm), INSOMNIA (could not sleep), BEDRIDDEN (bed bound), PARAESTHESIA (felt pins and needles down her arms; numbness like pins and needles on injection site and neck), RESTLESSNESS (and while laying in bed, she felt like she was driving a race card), THIRST (began to feel very very thirsty; drinking 1 liter of water), PALPITATIONS (racing heart), TREMOR (trembling in her upper body), CHEST PAIN (slight pain under sternum), MALAISE (felt uneasy), VACCINATION SITE PAIN (injection site started having pain), VACCINATION SITE SWELLING (her injection site started having pain, it swelled up), FATIGUE (fatigue), VOMITING (vomiting), PYREXIA (heat in her body), ARTHRALGIA (pain in her left knee) and NAUSEA (nausea) outcome was unknown and HYPOAESTHESIA (facial numbness and tingling) had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 02-Mar-2021, Blood pressure measurement: increased (High) increased. On 02-Mar-2021, Electrocardiogram: unknown (Inconclusive) unknown. On 02-Mar-2021, Heart rate: increased (High) increased. On 02-Mar-2021, Ultrasound Doppler: unknown (Inconclusive) result unknown. On 06-Mar-2021, Blood pressure measurement: increased (High) increased. On 06-Mar-2021, Electrocardiogram: normal (normal) Tests came back fine. On 06-Mar-2021, Heart rate: 110 (High) increased. On 06-Mar-2021, Oxygen saturation: 90 (Low) decreased. On 06-Mar-2021, Ultrasound scan: normal (normal) The tests came back fine. On 07-Mar-2021, SARS-CoV-2 test: negative (Negative) negative. On 18-Mar-2021, Blood pressure measurement: normal (normal) normal. On 18-Mar-2021, Electrocardiogram: unknown (Inconclusive) unknown. On 18-Mar-2021, Heart rate: 85 (High) Pulse was a bit higher than her normal.. On 01-Apr-2021, Fibrin D dimer: unknown (Inconclusive) result unknown. On 01-Apr-2021, Ultrasound Doppler: unknown (Inconclusive) result unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Per report, the patient had a skin eruption which was thought to be cellulitis at the clinic. Treatment included intravenous infusion with epinephrine, naltrexone, diphenhydramine, rizatriptan, naproxen sodium, TEA, a nerve supplement, and topical antibiotics. She was discharged home with EpiPen, prednisone, and famotidine. On 01 April 2021, the patient felt like she had a blood clot and received an EKG, D-dimer test, and ultrasound of the heart and lower limbs. On 07 April 2021, the patient reported feeling energetic. Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.

she almost passed out; dizzy; fast hearth beats; sick; high fever; throwing up; nausea; This spontaneous case was reported by a consumer and describes the occurrence of LOSS OF CONSCIOUSNESS (she almost passed out) in a 43-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Asthma, COPD, Cholesterol, Hypertension and Cyst of kidney (Cyst in left kidney). On 15-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Apr-2021, the patient experienced LOSS OF CONSCIOUSNESS (she almost passed out) (seriousness criterion medically significant), DIZZINESS (dizzy), HEART RATE INCREASED (fast hearth beats), ILLNESS (sick), PYREXIA (high fever), VOMITING (throwing up) and NAUSEA (nausea). At the time of the report, LOSS OF CONSCIOUSNESS (she almost passed out) had resolved and DIZZINESS (dizzy), HEART RATE INCREASED (fast hearth beats), ILLNESS (sick), PYREXIA (high fever), VOMITING (throwing up) and NAUSEA (nausea) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No treatments were reported. No concomitant medications were reported. Patient asked if she can receive another company's vaccine as a second dose.; Sender's Comments: This case concerns a 43-year-old female with a serious unexpected event of loss of consciousness, nonserious unexpected dizziness, heart rate increased, illness, and expected pyrexia, nausea, vomiting. Event onset the same day as first dose mRNA-1273. Events resolved. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.

Felt bad but went to work; Panic feeling; Extreme nausea; Anxiety; Facial swelling; Warm tingling at the injection site; Left arm swelling; Hot all over the body; Pulse was up; Blood pressure up; This spontaneous case was reported by a nurse (subsequently medically confirmed) and describes the occurrence of SWELLING FACE (Facial swelling) in a 43-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011J20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included Fever. Concurrent medical conditions included Asthma and Pollen allergy. On 08-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Jan-2021, the patient experienced SWELLING FACE (Facial swelling) (seriousness criterion medically significant), PARAESTHESIA (Warm tingling at the injection site), PERIPHERAL SWELLING (Left arm swelling), FEELING HOT (Hot all over the body), HEART RATE INCREASED (Pulse was up), BLOOD PRESSURE INCREASED (Blood pressure up), ANXIETY (Anxiety) and NAUSEA (Extreme nausea). On an unknown date, the patient experienced VACCINATION COMPLICATION (Felt bad but went to work) and PANIC REACTION (Panic feeling). At the time of the report, SWELLING FACE (Facial swelling), PARAESTHESIA (Warm tingling at the injection site), PERIPHERAL SWELLING (Left arm swelling), FEELING HOT (Hot all over the body), HEART RATE INCREASED (Pulse was up), VACCINATION COMPLICATION (Felt bad but went to work), ANXIETY (Anxiety), PANIC REACTION (Panic feeling) and NAUSEA (Extreme nausea) outcome was unknown and BLOOD PRESSURE INCREASED (Blood pressure up) had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 08-Jan-2021, Blood pressure measurement: 140/98 (Inconclusive) 140/98 mmHg and 182/108 (Inconclusive) 182/108 mmHg. On 08-Jan-2021, Heart rate: 118 (Inconclusive) 118 beats per minute and 132 (Inconclusive) 132 beats per minute. On 08-Jan-2021, Respiratory rate: 24 (Inconclusive) 24 breaths per minute. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. This case was linked to MODERNATX, INC.-MOD-2021-005905 (E2B Linked Report). Most recent FOLLOW-UP information incorporated above includes: On 14-Apr-2021: follow up received on 14-Apr-2021 included historical condition (asthma and fever), Allergically condition pollen allergy, lab data (blood pressure, heart rate and respiratory rate), concomitant medications (Symbicort Inhaler), treatment medication (Benadryl and Xanax), event (Panic Feeling).; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. MODERNATX, INC.-MOD-2021-005905:

This spontaneous case was reported by a health care professional and describes the occurrence of COVID-19 (COVID-19 pcr positive), PNEUMONIA (B/l pneumonia), HYPOXIA (Hypoxia), DIARRHOEA (Refractory diarrhea), NAUSEA (Nausea), VOMITING (Vomiting), FATIGUE (Fatigue), HYPOPHAGIA (Poor po) and ANAEMIA (Anemia) in a 43-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006B21A) for COVID-19 vaccination. patient is on chemotherapy (taxol for chemo)for breast cancer once a week. Concurrent medical conditions included Breast cancer (on week 3 of a 3-month cycle of chemotherapy with taxol), Hypertension, Depression, GERD, Drug allergy (allergic to clindamycin) and Obesity. Concomitant products included TAXOL for Chemotherapy, BUPROPION and TRAZODONE for Depression, OMEPRAZOLE for GERD, AMLODIPINE BESILATE (NORVASC) and LISINOPRIL for Hypertension, SENNOSIDE A+B (SENNA [SENNOSIDE A+B]) for an unknown indication. On 23-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Apr-2021, the patient experienced COVID-19 (COVID-19 pcr positive) (seriousness criterion hospitalization), PNEUMONIA (B/l pneumonia) (seriousness criterion hospitalization prolonged), HYPOXIA (Hypoxia) (seriousness criterion hospitalization), DIARRHOEA (Refractory diarrhea) (seriousness criterion hospitalization prolonged), NAUSEA (Nausea) (seriousness criterion hospitalization prolonged), VOMITING (Vomiting) (seriousness criterion hospitalization prolonged), HYPOPHAGIA (Poor po) (seriousness criterion hospitalization prolonged) and ANAEMIA (Anemia) (seriousness criterion hospitalization prolonged). On an unknown date, the patient experienced FATIGUE (Fatigue) (seriousness criterion hospitalization prolonged). The patient was hospitalized until 26-Apr-2021 due to COVID-19 and PNEUMONIA. At the time of the report, COVID-19 (COVID-19 pcr positive), PNEUMONIA (B/l pneumonia), HYPOXIA (Hypoxia), DIARRHOEA (Refractory diarrhea), NAUSEA (Nausea), VOMITING (Vomiting), FATIGUE (Fatigue), HYPOPHAGIA (Poor po) and ANAEMIA (Anemia) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In April 2021, Blood culture: negative (Negative) Negative. In April 2021, Computerised tomogram thorax: b/l pneumonia (abnormal) b/l pneumonia and negative for pe (Negative) Negative for PE. In April 2021, Influenza virus test: negative (Negative) Negative. In April 2021, Legionella test: negative (Negative) Negative. In April 2021, Oxygen saturation: 79 % (Low) low requiring oxygen. In April 2021, SARS-CoV-2 test: positive (Positive) Positive. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. Patient required oxygen during hospital course for hypoxia and was discharged home on it. Patient also needed two units of blood for anemia. Patient was not a candidate for regeneron or toci. Company comment :This case concerns a 43-year-old female hospitalized with serious unexpected events of COVID-19, pneumonia, hypoxia, diarrhea, nausea, vomiting, hypophagia, anemia and fatigue. Event latency 29 days from first dose mRNA-1273. Event outcomes unknown. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.; Sender's Comments: This case concerns a 43-year-old female hospitalized with serious unexpected events of COVID-19, pneumonia, hypoxia, diarrhea, nausea, vomiting, hypophagia, anemia and fatigue. Event latency 29 days from first dose mRNA-1273. Event outcomes unknown. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.

Shingles (small rash; tiny red pimples; spread throughout the entire left arm; pain was excruciating); Vaccinated arm became itchy and painful; Vaccinated arm became itchy and painful; Nausea; Fatigue; Difficulty breathing; Felt as though one half of my body was being weighed down and dragging; Tightness in chest; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of HERPES ZOSTER (Shingles (small rash; tiny red pimples; spread throughout the entire left arm; pain was excruciating)) in a 43-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 036A21A and 030M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included Chickenpox (aged 4) and Arm fracture (23 years ago) in 1998. Previously administered products included for Arm fracture: Morphine (23 years ago; reportedly had rash and was treated with diphenydramine (BENADRYL).) in 1998. Past adverse reactions to the above products included Rash with Morphine. Concurrent medical conditions included Drug allergy (morphine-rash), Alcohol use (occasional) and Non-smoker. On 08-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 08-Mar-2021, the patient experienced DYSPNOEA (Difficulty breathing), DISCOMFORT (Felt as though one half of my body was being weighed down and dragging), CHEST DISCOMFORT (Tightness in chest), NAUSEA (Nausea) and FATIGUE (Fatigue). On 15-Mar-2021, the patient experienced VACCINATION SITE PRURITUS (Vaccinated arm became itchy and painful) and VACCINATION SITE PAIN (Vaccinated arm became itchy and painful). On 16-Mar-2021, the patient experienced HERPES ZOSTER (Shingles (small rash; tiny red pimples; spread throughout the entire left arm; pain was excruciating)) (seriousness criterion medically significant). At the time of the report, HERPES ZOSTER (Shingles (small rash; tiny red pimples; spread throughout the entire left arm; pain was excruciating)) was resolving, DYSPNOEA (Difficulty breathing), DISCOMFORT (Felt as though one half of my body was being weighed down and dragging), CHEST DISCOMFORT (Tightness in chest), VACCINATION SITE PRURITUS (Vaccinated arm became itchy and painful) and VACCINATION SITE PAIN (Vaccinated arm became itchy and painful) outcome was unknown and NAUSEA (Nausea) and FATIGUE (Fatigue) had resolved. The patient reported no significant medical history. She reported immediately having difficulty breathing (also reported as 3 hours later). She noted a tightness in her chest and had to take her mask off. She rested at home but felt as though one half of her body was being weighed down and dragging with no other symptoms suggestive of a transient ischemic attack (TIA). On 15-MAR-2021, the vaccinated arm became extremely itchy and painful. On 16-MAR-2021, a small rash developed on her left arm. By the night of 17-MAR-2021, the patient realized that there was absolutely nothing normal about it and the rash had spread throughout the entire left arm, and the pain was excruciating and unbearable. There were tiny red pimples over the arm. The doctor said it followed "the nerve." No biopsy or specimen was obtained. The next morning, it was more intense. The inner forearm had pruritus which seemed like a bug bite. She saw a rash and went to the school nurse and was told it was in the vaccination spot. She covered it with a sock to apply pressure. On 18-MAR-2021, the patient went to the doctor and was diagnosed with shingles. Treatment medication included: valacyclovir started on 18-MAR-2021, naproxyn started on 18-MAR-2021, ondansetron for nausea prn, and nortriptyline until the rash resolved. Four days later, she was beginning to feel better with some rash resolution. Company comment: This case concerns a 43-year-old female with a serious unexpected event of herpes zoster, and nonserious unexpected dyspnea, discomfort, chest discomfort, and expected nausea, fatigue, vaccination site pruritus, vaccination site pain. Latency within 3 hours after first dose mRNA-1273. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded. This case was linked to MOD-2021-111460 (E2B Linked Report). This case was linked to MOD-2021-110352 (Patient Link). Most recent FOLLOW-UP information incorporated above includes: On 24-Mar-2021: Events added; treatment details added; product dosage updated; medical history updated; Sender's Comments: This case concerns a 43-year-old female with a serious unexpected event of herpes zoster, and nonserious unexpected dyspnea, discomfort, chest discomfort, and expected nausea, fatigue, vaccination site pruritus, vaccination site pain. Latency within 3 hours after first dose mRNA-1273. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded. MOD-2021-111460:Same reporter/different patient

Patient c/o feeling tachycardia, flush and dizziness, flushness upper torso neck region and bilateral upper arms. Rash/hives not present. Placed on stretcher , monitored immediately with BP 156/100, HR 88, O2 99%, alert and oriented x3, verbalizing clearly. Placed on EKG monitor, noted in NSR 80. POC 102. Shortly after at 1001, redness subside ,briefly noted with tingling of bilateral feet and hands for only seconds. Patient was monitored for 40 minutes, returned to baseline 142/81 HR 58 O2 100%. Nutrition given . Discharged to home, ambulatory feeling well.

Patient stated that she felt hot, internally. She then felt faint, dizzy. Her BP was elevated (115/99 mmHg) but pulse was normal (65 bpm). It did continue to change throughout her waiting/observation period (highest BP 158/110 mmHg and pulse 78 bpm). We observed her for 40 minutes when she stated that she felt ok to go home and rest. At that time her BP had normalized.

One hour post shot, heart beat went up to 120 at rest. Slight dizziness. This passed. Later in the evening compared injection sites with others in the household. Mine is redder, more swollen and seems more tender than others.

dizziness and stated "feeling heart palpitations or PVC's" . stated she had a history of PVC's before and had an ablation in 2012.

1/3: near syncope about 4 hours after receiveing vaccine 1/4: near syncope around 6pm, followed by joint paint, chills, fatigue, nausea, headacheInjection site extremely sore on movement.

Patient was vaccinated and in the waiting area. 5 minutes after the vaccine patient alerted staff she was having a rapid heart beat. EMS was onsite and responded. EMS personnel monitored patient for a short time. Patient stated she forgot to take her anxiety medication this morning. Patient returned to her vehicle and waited approx 5 more minutes and felt well enough to go home (husband was driving). Informed patient to call 911 or present to nearest emergency room if she starts feeling like she is having additional issues. Patient left site claiming to be feeling fine.

Individual received COVID 19 vaccine. Started to feel dizzy approx. 15 minutes after vaccine. Pt then started to have hypertension and increased confusion. EMS called, pt transported to hospital.

After left the clinic - 35 minutes post injection felt lightheaded, warm and some chest pressure. Clinic had ended. Sent to the ED for evaluation. EKG and Chest xray done - within normal limits. Discharged from the ED with a discharge note of likely vasovagal response

0912: Pt honks horn, this RN immediately to car side. Pt reporting tachycardia. Pulse check 106, BP 154/81. Pt states it came on suddenly, no CP, no SOB, no tongue swelling, no numbness/tingling, no throat itching or swelling. Pt monitored by this RN. After about 5 minutes pt reports feeling like HR coming down, HR 88 BP recheck 160/82. Pt reports no allergies, no adverse reactions to any previous vaccines (has received flu shot and Tdap in last 4 months). Pt did eat this morning. 1000: Pt observed in car, feeling WNL. BP recheck 133/76. Escorted to bathroom by this RN w/out issue. Pt states she feels comfortable driving, symptoms have completely resolved.

sore throat, esophageal pain, globus sensation Narrative: 12/23/2020 - felt like she had a lump in her throat. This persisted to 12/24/2020. on 12/25/2020 developed centralized chest pain and discomfort. No history of heartburn or indigestion. 12/25/2020 - went to ER. Diagnosed with esophageal spasm

Patient stated she had an elevated heart rate and suffers from anxiety/panic attacks. She stated she had not taken her Ativan today. HR was 133 and lowered to 78 after sitting in a chair with legs elevated on another chair. Pt was in a talkative mood and showed no outward signs of distress. She was reassured and after 30 min pt stated she felt well enough to leave.

Patient felt dizzy 30 minutes post injection, required extra observation and rest time to dissipate. She was slightly hypertensive 145/88 mm/Hg and 147/91 mm/Hg. Heart rate was consistently in the 80 BPM range.

SkinRash & Tachycardia Narrative: Staff member received the vaccine approximately @ 1030hrs. States she felt flush, tachycardic right after the vaccine. They developed a rash on her neck, chest and face.

On 1/7/21, at approx 1:05 PM, Maria noticed she was feeling very sleepy. Her co-workers noticed her left arm had bluish color, cold temp, and she had some tingling in her arm. Her blood pressure was elevated at 160/100. Patient was evaluated by Dr. and she recommended patient follow up in the ED. Patient was taken to ED by her Director. She states that ED staff told her this was a common reaction and that they would observe her for a couple hours. Her blood pressure decreased to less than 140/90. She states she was feeling better and returned to work at 4:40 PM to finish her shift.

Chills, headaches, extreme fatigue, muscle soreness, ongoing redness below the injection site, elevated heart rate, mild shortness of breath. I slept 11.5 hours the next night after receiving the vaccine, which seemed to help with symptoms. *I had a Covid infection in August 2020.

Moderna vaccine first dose. Almost immediately after receiving immunization, experienced rapid heart rate and hot temperature/flushing that last around 30 seconds before decreasing. No further adverse reactions other than moderate sore arm pain. Never had a reaction like that to a vaccine before Moderna.

I had throat & tongue swelling in the 15 mins after 1st covid vaccine/moderna..... EMS walking me out of school to ambulance & I passed out on sidewalk. And even I could not talk due to throat and tongue swelling and was getting weak. I was checked BP , it was over 150. I was transported to LG Alleghany - I received 1 epipen at the ambulance and another epipen in the ER. total got 2 Epipens. --- heart racing & shaking all over -- At the ER, took x-ray on lung and thorat , did EKG, and got Benadrly then slept for 40 mins or 1 hour.

Flushing, lump in throat, body aches , fatigue, sore arm, increase BP , increase heart rate after 10-20 mins post vaccine, then mild headache , nausea, metallic taste, dizziness for 3 days , then developed swollen lymph nodes on left supra clavicular area , fever, chills , extreme fatigue on day 4. Increase BP for a week, my BP runs low -my baseline.

Due to clients extensive history of allergies, client was placed in 30 minutes post vaccine observation by EMS. It was there client started experiencing " tingling and scratchy throat." Client's VS were taken at 1148 and as follows: BP 144/103, Pulse 85, O2 Sat 100%-EMS took over care and continued to monitor patient. At 1159 BP has increased to 158/95. At 1200 50 mg Benadryl IM was given in RDM. At 1204 BP had decreased to 148/86. EMS made the call to transport the client to Hospital for further evaluation and treatment.

Fatigue, chills, body ache, a little fever, night sweats, felt something heavy on chest, felt like walking on clouds, felt out of place. Symptoms lasted about 1 day & a half.

AFTER 24 HOURS OF VACCINATION STAFF IS VERY LIGHTHEADED,COMPLAINED OF WEAKNESS,CLAMINESS,UNABLE TO PERFORM DAILY ACTIVITY FOR 2 DAYS AND PALPITATION.

Woke up on 1/6/2021 with hot flashes, palpitations, dizziness and heart racing. Went to urgent care and they did an EKG which showed A-Fib, so I was sent to the ER and from there, I was transferred to an ICU at a different facility . I stayed until 1/8/2021. No cause was found and no history of A-Fib or family history.

approx 4.5 hours post vacc pt presents with moderate sized welps (4-5) on left forearm and c/0 itching. Pt assessed for and BP elevated to 160-180/100-120. No other adverse s/sx present, reported or visible. Pt assessed by Dr. Pt given 10 mg Zyrtec and observed 45 minutes. BP reduced to 140/100 and decrease in itching but welps remained unchanged. Dr. recc to see PCP next day for HTN eval. Pt reports she did go to PCP for HTN eval next day. No further adverse reaction reported.

high temperature of 108, chills, sore arm, headache, both feet felt uncomfortable with shoes on, pain in left chest area, around 11:45 pm breathing was difficult

Within 5 minutes of receiving vaccine dose reported feeling a change. Erythema on chest and shoulders observed as well as Hypertension BP up to 172/104 and fever up to 101. This persisted for 20 minutes even after 50mg of Benadryl was administered. Ultimately an emergency response was initiated and taken to ED.

5 minutes after vaccine administer reported feeling changes. Erythema on chest and shoulders observed. Hypertension up to 172/104 and fever up to 101. Symptoms persisted over 20 minutes and emergency response was called for ED visit

Patient, a 44 year old female received Moderna vaccine in L deltoid on 1/5/2021. On 1/6/2021, pt reported to vaccine clinic at 1130 with c/o racing heart and nausea. VS obtained. EMS called and patient transported to ER. Macular rash noted on chest per ER report. During time at ER, pt given IV fluids and PO Tylenol 1,000mg. Pt discharged home in stable condition with recommended follow up with PCP.

20 seconds post vaccine: Flush and dizziness 5 mins post vaccine: tingling tongue, flush, dizziness 15 min post vaccine: symptoms as above, tingling below knee to feet 30 min post vaccine: symptoms as above, facial/jaw tingling/felt swollen, ears hot/swollen -- took diphenhydramine 25mg 45 min post vaccine: tongue and face started to feel better, tingling moved to back of throat with mild difficulty swallowing 60 - 90 min post vaccine: took another 25 mg diphenhydramine and 10mg claritin. Symptoms started to subside 3 hours post vaccine

The day after recieving the shot I woke up with chills, Ache , fever. Temp. was 101.0, took tylenol. The next morning I felt a heaviness in my chest. Patient continue to experience aches, chills and fever.

About a 4 by 6 inch area that is whelped up, red, itching, and throbbing. I saw a Dr. yesterday. She prescribed Cephalexin antibiotic.

Myalgia chills, fatigue, syncope vs seizure 43 yo employee falt fatigue on 12/24 and again on 12/25/20. The patients husband reports she was walking down the stairs, seemed "off" and missed the step/slid on step injuring both feet/ankles. Pt got up and was able to stand for a few minutes. Husband reports that he than sat her on the steps-few minutes later she had syncope with convulsions vs seizure. Per his report this lasted over a minute, she stopped breathing and was unresponsive. He reports she was confused while he was on the phone with 911 operator (3 minutes). Patient was taken to Health Center for work up. The head CT, labs, X-rays, EKG were unremarkable. Followed up her physician Dr. and was referred to neurologist. She had a MRI without contrast which was unremarkable and is scheduled to undergo a sleep deprived EEG. She is undergoing physical therapy at this time for injury to bilateral feet/ankles.

Immediate onset headache; 35 minutes later developed chest tightness and sensation of being "squeezed around the ribs"/chest area. Arrived to walk-in clinic at 03:50 p.m. for evaluation. Tx: self monitor. Outcome(s): condition continued at patient discharge to home

reported chest heaviness SOB , believed it was an asthma attack.12/28 was seen by cardiologist and sent home on 12/29 was seen by cardiologist , had an echo and sent home on steroid

The day after I received vaccine I had severe arm pain at injection site, my body was achy , and fatigue. These symptoms resolved after a few days . I then had dizziness, nausea, unbalanced when walking, chest pain, feeling like my heart was racing, palpatations, muscle weakness in my legs, and brain fog. The unbalanced feeling, dizziness, weakness ,and occasional palpatations remain. I had a covid test done on 1/6/2021.I had sinus pain started on 1/8/2021. I am being treated for possible sinus infection with Augmentin that I started on 1/11/2021 but my symptoms are still present . I have been unable to work because when I walk I feel dizzy and unsteady. I have follow up with my primary doctor on 1/18/2021.

Pt reported feeling ill after returning from lunch, visibly shaking, heart racing, sweating, feeling like something catching in her throat, numbness in fingertips and lips. Placed in supine position with legs elevated, administered Benedryl 25mg IM at 1359. BP 148/96, HR 118, O2 sat 98%. Dr. in room, checked mouth and throat - noticed redness but no swelling. Used alcohol under nose, pt did not feel any better and was reporting that she felt like she was spinning. @1416 BP 140/90 Blood glucose check, 116, HR 101., O2 sat 99%. Pt observed and remained in supine position. @1441, pt reported feeling better, BP 128/79, HR 88, skin warm and dry. Assisted to a standing position. Reported spinning had stopped and was able to ambulate. Pt sent home to rest with instructions to call if worsening or call EMS.

Five minutes after injection, experienced a sense of doom, shortness of breath, and blood pressure/heart rate significantly above baseline. I was monitored with vital signs for the next 45 minutes and the symptoms resolved. For the next several days, experienced injection site pain and fatigue.

Approximately 3 minutes after vaccination, sitting in chair and had a bout of dizziness and racing heart rate. This lasted about a minute. Ten minutes after, experienced flushing lasting about a minute as well.

Approx 25 minutes after receiving the dose, patient complained of itching on her chest and also a sensation of itching and tightness in her lungs. Has had this sensation before with allergy to mold. Gave 50mg of benedryl and monitored. Sensation did begin to improve about 30 minutes after benedryl, and continued to improve,

At 0915 she reported arm and finger tingling, chest and throat tightness, and heart racing. Took sips of water. Able to talk and hold conversation with nurses. At 0925 she reported that she had another "wave" of these symptoms which would quickly resolve. EMS called at 0930 because she had a third "wave" of these symptoms and stated that the tingling extended down into legs. Went to Medical Center at 0940 with EMS.

1 hr and 15 minutes after receiving the shot I had a wave of dizziness come over me. Suddenly, my heart rate increase to over 180 beats per minute. I laid on the couch for an hour to relax and try to get it to slow down. Heart rate did not. Checked heart rate multiple times on a blood pressure machine and it was in the 180's. After an hour I went to the ER.

Patient stated she felt dizzy, and was slightly hypertensive (150/85 mm/Hg & 158/90 mm/Hg) She denied shortness of breath or chest pain and the dizziness subsided

Woke up the next morning after receiving the vaccine, and felt horrible. Fever 101, aches, chills. Was only out of bed for a couple of minutes, knew that something was not right, and then I passed out on the floor for at least 15 minutes.

Patient felt shaky, hot and racing heart with a dry mouth. Symptoms subsided with in 15 minutes and she felt much better. Did advise her to follow up with her physician and if signs and symptoms develop or worsen she should seek immediate medical attention.

Lightheadedness, faintness, fatigue the night of receiving 2nd dose. Morning following second dose patient passed out while taking a shower and injured her arm. Contusion and bruising was prominent

At 6:45AM on 1/19/21 patient developed numbness and tingling on right side of body which progressed to right hemiparesis and right-sided facial droop. Brought to ED by EMS and worked up for stroke. Found to have acute infarct on MRI and treated with dual antiplatelet therapy.

Arm gradually became more painful. Difficulty driving with left arm at 8 p.m. Got into bed with chills. Around 3 a.m. woke with a massive headache, chills and sweats, joint and muscle pain. Went to the kitchen for a glass of water and to take Ibuprofen but almost blacked out. Sat on the floor and placed forehead on cold tiles because of sweats and nausea. Crawled to the couch and remained there until 8 a.m. Moved to bed. In and out of sleep with mild chills and sweats the rest of the day.

Tingling of palate. started 5-7 min. after receiving the vaccine Difficulty breathing, tachicardia, hypertension lasted about an hour- hour and half but hard to say until benadryl kicked in. TReated in ED with IV benadryl and pepcid . I left the hospital 5 hours later with normal vitals of heart rate in the 60's and b.p. 112/62

30 Mins after injection felt like I had consumed caffine, heart was racing. 1 week after the injection I still had migrains. 2 weeks after injection, injection site is still painful and the site has a bright red rash.

Friday 1/22-11am recived shot 3pmLeft arm soreness 4hrs after then started to feel the flu like symptoms chills severe body ache joints pains temp 104 one time then down to 99.8. Until Sat 3pm starts ti feel ok but buy sunday started the chills and achy joints and body ache again.then temp 101 in early morning of monday.the whole day gets better until ealry am of tuesday got the chills and joint pains.been on rtc ibuprofen 800mg and tylenol 500mg thr whole time.im still monitoring myself until today while im reporting this.

Symptoms: facial and chest rash, itching, chest tightness, tachypnea Treatment: Pepcid, Benadryl, Solumedrol Outcome: Discharged home

Sudden onset of substernal chest pain radiating to back. Headache radiating to left shoulder and redness of hands

Adverse event: Vomiting, diarrhea, chills, sweating, headache, body aches, heavy feeling in legs, heart racing, arm pain Treatment: rest, pain medicine, liquids Outcome: side effects subsided by Monday afternoon (1/25/2021)

Patient experience chest tightness, dizziness, and attempted to lie on floor after 15 mins in observation (19:10). Vital signs was taken, initial blood pressure was 145/90, and HR of 101, Respiratory rate of 22. Patient stated presenting the adverse reaction right after vaccination, but patient did not notify healthcare providers (RNs) until patient complain of chest pressure, patient notified 15 mins after injection. Patient requested EMS to be activate. Vitals signs was continuously monitored, until EMS arrived at 1930. Last set of vital signs was HR 123, RR 17, BP 132/82, O2sat 99%. EMS arrived At 1930 for evaluation and transport patient to hospital.

Became dizzy within 30 minutes, then body shakes (not chills), palpitations and a skyrocketing bp and pulse. My throat was also sore (but not constricted). I work in a medical facility and was brought to the Emergency Department. I was monitored with an EKG and given steroids and benedryl intravenously. I was discharged from the ED after a few hours and told to return to an emergency room if symptoms got worse again. My blood pressure continues to be somewhat elevated and heart rate feels rapid at times. Also intermittent dizziness., along with other common post vaccination side effects.

Tongue started to swell, tingling lips & heart racing. Reaction lasted for 5-10 mins. Didn?t notify EMS

Chills, shivering, sensation of swelling in throat and beginning of hives (patchy red area on arm), some shortness of breath, palpitations and elevated blood pressure. Went to emergency room for observation. Diphenydramine administered at ER.

Headache, nausea, body aches, chills and fever (highest 101.1) began around 1am 1/26/21 and continued throughout the day, fever finally breaking around 7pm that night. I woke the following morning 1/27/21 at 7:20a feeling better, only slightly tired. I was awake about 30mins when my husband reported I stated I felt very dizzy while standing in our kitchen, he states I started walking over to our living room when I fainted and fell face first into the side of our sofa. He stated I came too about 20-30 seconds later. After awaking my hearing was muffled and my arms were very tingly for about 3 mins. I felt completely exhausted and slept for a few hours, remaining very fatigued the rest of the day. Today, 1/28/21, I woke up feeling tired but tightness to base of my head and neck, no other symptoms.

Within an hour I had a headache. By 4 hours my arm was very sore. At 8-13 hours I felt like I had the flu with body aches, chills, and sweating. Between hours 14-44 my experience was intense with fever >102 (that was not responsive to Tylenol or Motrin), uncontrollable shaking with an episode of urinary incontinence, fainting, rash on chest/neck, right facial twitching, right arm twitching, nausea, vomiting, diarrhea, chills, profuse sweating, flashing lights in both eyes (open and closed), intense body aches, the sensation that my skin was burning, muscle spasms (back), joint pain (knees/hips), dizziness, agitation, and insomnia. After 44 hours the intense symptoms resolved and I had fatigue, right facial twitching, right arm pain/itching/redness. I went to see my doctor on 1/28/2021 to document my experience.

At first I was feeling dizzy, then the back of my throat felt itchy. EMS came over, and took my temperature, which was 98 degrees. Then I started to feel compression and pain in my ribs on both sides, and the middle of my chest - like an elephant was sitting on it, or I had a corset wrapped too tightly around my diaphragm. Then I started having uncontrollable coughing fits, followed by wheezing. EMS got me some ice packs for my ribs and the middle of my chest, but I had to get up and use the bathroom. When I get anaphylaxis, I usually take two aspirin, a benadryl, a cetirizine, a CBD capsule, a famotidine, a 20 mg steroid pill, and a hydroxyzine pill - all at once. EMS agreed I should take it, and they gave me a shot of epinephrine in the arm. then they loaded me on to the ambulance, where I got a shot of steroid, and we went to the hospital in. EMS also started an IV for me. At the hospital, they gave me another shot of EpiPen, over 20 minutes after the first one, and a shot of Benadryl. by the end of 2 hours, my breathing was back to normal, and I was able to go home. Today I still feel a little bit dizzy, but mostly my arm is sore where I got the vaccination. I also still have a headache.

Chest Pain-ongoing tongue tingling- lasted 1 week Lightheaded- ongoing dizzyness - ongoing arm weakness and soreness- ongoing

Anaphylaxis: hives all over her body, lightheadedness, throat closing. Hypotension about 2 hours after the moderna was administered.. She received 2 doses of epipen before paramedics took her to the ER.

Allergic reaction, initial encounter Left arm heavy numb to wrist Throat numb felt as if swelling Face numb eye pain floating spots nausea headaches Cold Rapid heart beat monitor breathing and BP rates Went to hospital via EMS

Chest tightness and rapid heart rate - up to 135 beats per minute. History of anxiety. Patient requested EMS.

Less than five minutes after vaccine administration, the patient developed pruritis, cough, and headache. Blood pressure was mildly elevated at 140/90 and O2 saturations were over 97% on RA. She was given 12.5mg of Benadryl and symptoms mildly improved. She was taken to the Emergency Department for observation. She was treated at the ED and was discharged the same day.

Within 5 minutes, I felt weird and light headed. My blood pressure spiked, temperature spiked to 101, heart rate was elevated and continued to be elevated for about 12 hours, and there was a rash across my chest and upper arms. On 1/14, I was extremely tired. On 1/15, I had a sore throat, headache, and still slightly tired. As the days went on, the cold symptoms got progressive worse. Extremely congested, runny nose, extremely painful headache, coughing up pflegm, sore throat, etc. On Wednesday, 1/20 I had a fever of 101. I had these cold symptoms for a week and a half and that was when I called my doctor. She gave me an antibiotic. I was on the antibiotic 1/26 - 1/30. Today is 2/4 and I'm still coughing. Something weird also happened, smells changed. My coffee smelled awful and other things seemed extremely strong.

Anaphylaxis reaction; Angioedema; Shortness of breath; Wheezing; Fast heart rate; A spontaneous report was received from a physician concerning a 44-year-old, female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced an anaphylaxis reaction, angioedema, shortness of breath, wheezing, and increased heart rate. The patient's medical history was not provided. No relevant concomitant medications were reported. On 20 Jan 2021 at 18:00, approximately 10 minutes prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Lot number: 041L20A) intramuscularly for prophylaxis of COVID-19 infection. On 20 Jan 2021, approximately 10 minutes after receiving her injection, the patient began to have tongue swelling. She was given diphenhydramine and epinephrine by epi pen. She went to the emergency room where she displayed symptoms including a fast heart rate, wheezing, and shortness of breath with an angioedema or anaphylaxis like appearance. She was given more epinephrine, famotidine, scheduled diphenhydramine at 50 QAs intravenously (IV), IV steroids, was intubated and placed on a ventilator. She was on the ventilator for approximately 18-20 hours following admission. She eventually responded to a high dose of dexamethasone. She was also given duonebs for her shortness of breath, regular sedation for the ventilator, and a dose of ketorolac. Consent was given for Safety to follow up. Action taken with mRNA-1273 in response to the events was not reported. The outcome of the events were unknown at the time of this report.; Reporter's Comments: This case concerns a 44 year old female patient who experienced a serious unexpected event of Anaphylactic reaction. The event occurred approximately 10 minutes after first dose of the study medication administration. She was treated with epinephrine, famotidine, diphenhydramine, IV steroids, intubated and placed on a ventilator. Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.

on 1/29/21 states had 2nd covid vaccine on 1/26/21- felt faint after the clinic, on 1/28/21 didn't want to eat or drink, hrt rate 110, BP nl, laid down to rest, Hrt rate was 80-100, had EKG which was nl with pulse 90, went hone and rested, noted going up stairs pulse would inc to 130, felt dizzy, pulse would then go down to 80's after, has now been eating and hydrating; communication 1/30/21-sx resolved

Thursday, 2/21 - started feeling, overall, exhausted, and having lots of aches and pains. My chest and back (near area where I have costochondritis (xiphoid process) was in a great deal of pain. My heart rate also kept jumping around between 65 and 105 without exertion. Tuesday, 1/26/2021 - I was feeling exhausted and got out of breath with minimal exertion. Heart rate jumped up with minimal exertion (e.g. just standing, heart rate climbed about 110). I also started feeling dizzy and , ultimately, fainted, which put me in the emergency room, where they ruled out a PE and all cardiac emergencies. My blood pressure spiked with a systolic around 165 (my usual is 90-95). Labs indicated everything was fine. The only thing different than usual was the vaccine. This was also the day I realized I developed extreme cold feet and also cold fingers, ears, and nose. My cold feet is still an issue - they get so cold, it?s actually painful. I now have to have a heating pad around my feet at home. This has never happened to me before the vaccine in my, now, 45 years alive. I?m still a bit fatigued, have sporadic aches and pains, sometimes get a little dizzy, and have extremely cold feet...two and a half weeks later.

Approx. 14 hours after receiving the 1st part of Covid vaccine my arm became so sore I couldn't move it. It was sore from my neck down to just below my elbow. I began having chills and a low grade temp shortly after that. by 0130, I was dizzy, experiencing diarrhea, with episodes of diaphoresis, and acute nausea. I felt that I had some postural hypotension, was very pale and every time I would get up to walk I felt like I was going to end up on the ground. I remained in bed for approx. 16 hours before I felt like I comfortable even getting up and going to restroom. I still have intermittent dizziness, with syncope to this date. I had to leave work early as well as calling in sick for the next shift.

I felt fine after the vaccination at 11AM. Between 1-3:30PM, I got a pedicure and drank two 5.4% alcohol beverages. I drove home, made dinner, and ate. Shortly after eating, around 7:00PM, the soreness in my arm got intense, I began feeling nauseous and disoriented. I went to the bathroom and got on my hands and knees because I thought I was going to vomit. My boyfriend helped me get up on the edge of the bathtub, but I quickly passed out and fell forward. He said I was out for approximately 30 seconds. I came to long enough to tell him to call my mom then passed out again. for about 15 seconds Within minutes my mom, sister and daughter arrived, followed by first responders. First responders had to keep me from passing out for about 10 minutes, during which time I broke into a cold, soaking sweat, had involuntary muscle convulsions, extreme nausea, disorientation, slurred speech, and loss of ability to get up or walk on my own. I was admitted to the emergency room around 7:45. It took another hour for me to regain muscle control, speech and total coherency. I was released and went home. My arm was severely sore until Monday morning, but I also experienced severe fatigue, nausea, headache and muscle aches until late Sunday.

Patient stated she felt hot and heart rate was rising. Staff vital patient and was 175/110 with pulse of 85. Doctor spoke with her and checked her out and we vital again around 2:30pm and was 134/82 with pulse of 85. Patient was observed another 15 minutes and she stated she felt a lot better and was cleared to go. Patient was called at 5:30pm and stated she felt good.

While PT was in her 15 minute observation period PT began to experience weakness with a near syncope, later complaining of chest pain. PT was found to be hypertensive BP 200/100. PT advised she has a PMH of HTN but did not take her prescribed medication in the morning. PT remained hypertensive and was found to have an irregular heart rhythm with no history of cardiac issues. IV was established, 325 mg of aspirin via PO was and 0.4 mg of nitroglycerin was administered via sublingual with PT chest pain improving from 8 of 10 chest pain to pain completely subsiding. Run #21-0766

10 minutes post second COVID vaccine, reported "floaters in vision," mild central chest pressure and elevated blood pressure 200sys/100dias and felt her "heart racing" pulse measured 101. after monitoring for approximately 30 min we decided to send to ER.

Nausea, dizzy, feel heating all body , heart beat fast for1-2 min then back to normal and fast heart beat again in 5 minutes for 1-2 minutes. It happened for 20 min then stop, only mild dizziness and nausea still come sometimes for a few hour. It feels better after after drink cold water and resting.

Headache around 6pm with nausea I took ibu and went to bed early. Tuesday still bad headache getting worse and then I noticed swollen lymph nodes under left armpit. Wednesday left arm nodes really swollen and still headache so called primary dr. Took ibu and went to dentist appointment at 1pm and still had headache and blood pressure was 219/109. Since the vaccine I`m not getting blood pressure under control and i`ve never had high blood pressure. Please help?

Heart palpitations began about five days after vaccine. Started just a few times a day, but increased to several times per hour over the course of the last two weeks. I have just visited my GP to investigate. Lab tests and heart monitor have been ordered.

Vasovagal syncope after getting up to urinate, hit head with loss of consciousness for 10-15 minutes, sustained concussion, admitted overnight for testing and observation.

5 min after Vaccine administered pt. fingers started to feel tingly then throat started to feel numb. BP elevated, alert and responsive. 25 mg Benadryl given PO 20 min later. Observed x 1 hour, VS stable, Throat still feeling numb but not worse. Given 25 mg Benadryl PO and observed 1 more hour. Pt feels the same, VS stable, alert and responsive with no resp. distress noted. Pt. left clinic. Reached out to pt. several days later with no answer. Message left with emergency protocol.

Axillary Lymph swelling with erythema extending from insertion site streaking medially to the axilla. Pain to axillary region and upper arm with tingling and heaviness to lower arm.

Temp- 102, chest pain, body aches, headaches, vomiting. Saw primary in the AM and went to the ER from there.

My left arm, where I received the shot, began hurting after a few hours. Approximately 12 hours after receiving the shot, fatigue began. Approximately two hours later, I was unable to walk, I collapsed on the floor, my heart was racing, I was sweating, my entire body went numb, and there was ringing and static in my ears. After about 20 minutes on the floor, I got back into bed. My fingers and hands wanted to curl up and not open and that lasted throughout the night. My arms and legs stayed numb all night long. At around 24 hours post vaccine, the numbness started to subside, I could open my fingers and hands, and regular flu symptoms were present (fatigue, body aches, low grade fever). I could not work the day after receiving the shot. I slept all day. I was not able to drive until around 5PM the day after receiving the shot. The second night and throughout the following day (so 36-48+ hours post shot), I had cold sweats. It is now 3 days later and I still feel terrible. I am worried about getting the second Moderna shot.

Pt c/o dizziness, heart palpitations, and 'shaky' feeling after receiving injection. Pt reported her bp does run high. Pt given oral hydration and snack which improved most of the symptoms but still felt shaky. Initial VS 174/97 HR 109 SaO2 96. Recommended to go to ER after 30 minutes of observation. Pt declined. Dismissal VS 147/104 HR 83 Sao2 98. Pt left ambulatory

Pt given 0.5cc COVID #2 injection (Moderna), was waiting in patient area for 30 minutes due to h/o other reactions previously. 20 minutes after injection, pt remarked that she felt hot. Brought back to resp clinic, wasn't having any SOB or CP, didn't appear very flushed. Was shaking. Pulse ox applied, O2 stayed between 98 & 99% RA. HR was initially in high 80's (pt on 50mg metoprolol QD), climbed up to 109. BP (lg cuff, rt arm) was 144/91. Pt became nauseated, vomited phlegm. Did not feel presyncope. Ice applied to back of neck. No redness at injection site. Heart exam: no murmurs or irregular heartbeat; lungs CTA throughout, no stridor or wheezing. Pt remarked that the heart racing, shakiness & heat felt like previous times when she was given racemic epi for reactions. Was monitored for 30 minutes, HR stabilized in low 80's, sensation of heat dissipated. Was allowed to leave 50 minutes after vaccination given, and advised to call for EMT if symptoms came back. She expressed understanding, and was told to NOT drive herself home (family member was with her).

Heart palpitations- began about 4 weeks after first dose of vaccine, have been intermittent since then, increasingly uncomfortable. Headache Fatigue

Left leg began hurting one hour after shot. Throat started to swell causing increased clearing of throat, swollen glands, with difficulty swallowing. Throat, esophagus was swollen 5 hours later. Went to emergency room and was given Benedryl, Epinephrine, Pepcid, and Solumedrol. Kept in ER for 8 hours, Throat still swollen, but better, provided second doses of Benedryl and Epinephrine, then admitted for observation for 24 hours. Throat and swallowing difficulties continued for approximately 3 days after discharge. Hoarseness, difficulty swallowing, having to push liquids and food into diaphram was uncomfortable.

About 12 hours after the shot, I started running a fever and was very achy. It got progressively worse. Around 4:15 am I got up to use the restroom and I passed out. My husband was able to get me to regain consciousness. I then passed out again after about 10 minutes. We then went to the ER because I had a laceration on my eye,and head pain from hitting my night stand, wall, and floor.

0911: 20 minutes post-vaccination patient reported feeling "short of breath" , "throat starting to swell" and "chest heaviness". Upon assessment patient is pale, tachypneic, wheezes noted in bilateral upper lobes, alert and oriented x3, No visual rash or angioedema. BP 160/100, O2 98% RA, HR 91. Patient reported history of anaphylaxis to "allergy shot at age 17" but has since had vaccines with no reactions. 0912: 911 called for ambulance/medical transport 0915: 50 mg Benadryl administered IM left deltoid 9:20: 0.5mg Epinephrine administered IM left deltoid 9:22: patient transported via ambulance to St.Marys Healthcare Emergency Department Amsterdam NY.

Several (>4) hours after vaccination patient started feeling fevers and severe body aches - presented to ER where she was found to be borderline hypotensive (systolic BP 80s v. baseline low 100s) - received IV fluids with resolution. Observed inpatient for 24 hours.

Pale, clammy, diaphoretic associated with vomiting and near syncope 12 hours status post vaccine. Then within 24 hours post vaccine developed burning in chest. 36 hours post vaccine severe chest pain. Described as elephant on chest radiating down left arm to left jaw associated with paleness and diaphoretic. Hurt to take in deep breath and pain worsened upon lying down. Relieved with motrin 800 mg. I continued motrin every 6 hours until I could follow up with cardiologist on Friday 01/29/21. EKG showed ST elevation in all leads. Stat echo was performed at facility. Diagnosed per doctor with acute Pericarditis. Started on Colchicine 0.6mg twice daily X 10 days. Other doctor followed up and continued Colchicine 0.6 mg x 90 days.

I had Covid-19 in December 2020. On the following day of my first vaccine, in the middle of the night, I experienced chills, body aches. At 7am the next day I woke up feeling light headed and passed out. When I woke up I had thrown up on myself and started to hear a whooshing sound in my ears and I went back to bed. At 9am my symptoms started all over again. I live with my house maid and since I did not look well, she took me to urgent care. My BP had dropped and I was super dizzy. I got an IV drip for an hour, anti-nausea medication. My blood was also drawn and found to have underlying anemia. My urine test was negative. The pulse oximetry was fine and by the next day I slowly started to feel better.

1 week after shot I ,got " arm" that lasted 4 days along with chills and very sore/ achy legs making it hurt to walk. I still have leg achyness and dizziness that prompted me to call my doctor to note it in my chart. on March 1, 2021. I soaked my legs in an upsom salt bath for comfort. I now have light bruises on my legs and some feet and left hand tingling/numbnes. My heart rate is elevated at different times of the day with simple movement; walking to kitchen or bathroom. Some dizziness/brain fog at given moments throughout the day.

Initially there were severe flu like symptoms: chills, shaking, headache & body aches, fatigue starting apx 2 hours following. These continued until apx 24 hours later when additional mental fog set it, difficulty focusing attention, lethargy, trouble walking, dizziness then brief loss of consciousness occurred, extreme difficulty staying awake. I was taken to the emergency room where additional tests were done due to "stroke- like" symptoms. Tests were okay with hospital staff reporting that likely/only known cause was the COVID vaccine given the day before. Symptoms have gradually reduced but occasional mental fog, occasional dizzy spells & chronic fatigue persist.

First I got a headache, then I felt extra mucus in my throat. Then I started feeling compression, pressure, and pain in my diaphragm; and then the middle of my chest. Finally, I started coughing, and I wasn't able to breathe. I had told all of the nursing staff that I had anaphylaxis to the first shot, but they acted like they didn't believe me. Also, there was no EMS staff on hand this time, unlike the first time, where they were on site. I think that made the difference in my medical care, because my husband heard the nurses at the facility say they were treating me for anxiety, not anaphylaxis, despite the fact that I was getting worse. The nurses on staff didn't seem to understand or believe that a person could have anaphylaxis from the Covid injection, even though it's on record at the hospital that that's what happened the first time. It wasn't the same staff as last time, which also contributed to the problem. Once the ambulance staff got there, he took me seriously, and finally administered an EpiPen, and also put me on oxygen, which helped a little bit. that was the most comprehensive care I got that day, from someone who was actually listening to me he also took an EKG, which which was normal. When I got to Facility, the treatment wasn't as good as last time, either. Apparently they've been really busy the day before, and all of the staff seemed fatigued because of it. Nobody really checked on me, offered me even ice chips to moisten my mouth, and didn't offer me any assistance in getting to the bathroom, either. a respiratory therapist came in to give me a couple puffs on an albuterol inhaler, and I got a Benadryl shot, but nothing else. I think if I had not taken my coterie of prescriptions to stave off anaphylaxis, it would have been worse. 20 minutes before the shot I took: two aspirin, a CBD capsule, and one each of the following pills -cetirizine, benadryl, famotidine, 20 mg of prednisone, hydroxyzine. I think that's what enabled me to recover with only one EpiPen, instead of two, like last time. if there's a third Moderna shot for the varients, or a booster, I'll try to take all those pills an hour beforehand, and see if having them in my system for a longer period of time we'll make the difference. It will be nice to have *no* anaphylaxis, and skip the hospital trip . Since then, it's taken me about a week to recover fully, the same as after the first shot. I've had problems breathing, fatigue, muscle aches and pains, flushing, fever/chills, and in general just felt like I had the flu.

Injection site pain began approximately 2 hours following injection and continued to intensify and spread down the arm and up the neck and upper back over the next hour. A headache and intense fatigue began and I took 500mg Tylenol at that time. Approximately 30 minutes later I unintentionally lost consciousness and awoke several hours later confused and disorientated. I arose to get a drink of water and was unable to walk, falling twice within approximately 10 feet. I noticed my vision was affected as the entire room appeared to be rocking left to right even though I was holding myself still in an attempt to steady my sight and balance. I immediately went to bed and have no memories until I awoke the next morning. At that time, my vision and balance had returned to normal though the aches and pain in my arm, neck and back persisted. This pain slowly dissipated over the next 3 days.

Vaso vagal response with 1st covid vaccine Vital Signs: HR 70 Resp 14 O2Sat 98 Skin Signs: Warm and dry Circulation: Cap refill <2sec As a precaution, pt waited 15 min in triage area with RN. Juice and snack taken. Pt escorted to vehicle by RN without incident. Parents waiting. Pt denied symptoms with 2nd vaccine. Pt denied symptoms of vaso vagal response. Tolerated 2nd vaccine without incident.

I stood up from a sitting position after smoking a cigarette and got a headrush that traveled through whole body , and then I fainted for a few seconds. After the first event, I never fainted again but had several headrush like dizzy spells over the next few weeks. These spells would last for 1-2 minutes, originally only occurred after smoking a cigarette, but then began to happen when I would stand from a sitting position when not smoking, and I would need to sit back down until the headrush passed. This reaction occurred periodically up until one week before my second shot (01/23/2021), and I have not experiences it since, not even after my booster shot. I understand it may not be related, however, I have been smoking for 30-years and have never experienced a reaction such as this one before.

Pt had an immediate (within 2 minutes) onset of light headedness and shaking after getting the vaccine at about 10:30 AM After about 10 minutes, she reported to me that she was feeling very shaky, chest tightness, tongue swelling and difficulty swallowing. She thought it might be anxiety and wasn't convinced it was an allergic reaction, so we decided to monitor her. I continued to monitor and she said she was starting to feel a bit better, but not well. At 11 AM, I decided to start taking blood pressure. BP readings were 11 AM 117/66, pulse 76. 11:05 122/77 pulse 69. 11:15 130/84 pulse 102 at which time pt reported not feeling well and we decided to lie the pt down and administer an Epi-Pen. 911 was called at that time, epi-pen was adminstered at around 11:18 AM. 11:20 BP 130/90, pulse 69. within minutes, EMT arrived and started to monitor pt. Pt was released at 11:40 AM refusing transport but her husband was going to drive her to ER for monitoring. Unaware of her status at this time. Will update it when I know more.

Vomiting, fatigue, headache, dizziness, chills, low grade temp, loss of taste, difficulty breathing, rapid heart beat. The vomiting stopped yesterday. Rapid heartbeat and dizziness started within 10 mins of having the vaccine.

Approximately 30 minutes after receiving the vaccine, I began to experience coughing and a tightening in my chest. This lasted for another 30 minutes.

Developed Dizziness / lightheadedness immediately following the injection . Remained alert and lucid. Blood Pressure rose to 248/124. Pulse Approx. 92 min Sent to Emergency Room via EMS for complete assessment Patient mentioned that she developed localized cervical adenitis following the 1st dose of vaccine Impression: Hypertensive Reaction to COVID vaccine. Hypertensive emergency .

Migraine headaches, dizziness, nausea, weakness, numbness, pins and needles, palpitations, ringing in ears, clamminess, hot flashes